Manufacturer registered with FDA
Dentsply Sirona, Inc.
York, PA, United States. Lists 106 dental device types with FDA across 30 registered establishments, and holds 148 510(k) clearances as applicant.
- Device types listed
- 106
- Brands and models
- 289
- 510(k) clearances
- 1481988–2026
- Markets registered in
- 186,454 registrations outside the US
- Establishments
- 30Belgium, Brazil, Switzerland +9
510(k) clearances per year, 1980–2026
Registered in 18 markets
Where regulators' registries name Dentsply Sirona, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dentsply Sirona, Inc. | 148 clearances | 1988–2026 | Below |
| Canada | Health Canada | Registration holder | DEGUDENT GMBHDENTSPLY SIRONA ORTHODONTICS INC. · SIRONA DENTAL SYSTEMS GMBH · +2 | 2,106 | 1999–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | ZHERMACK S.P.AZHERMACK S.P.A. · VDW GMBH · +2 | 1,296 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Degudent GmbHSirona Dental Systems GmbH · DeguDent GmbH · +2 | 571 | 1998–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Maillefer Instruments Holding SarlSIRONA Dental Systems GmbH · DENTSPLY DeTrey GmbH · +2 | 494 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MAILLEFER INSTRUMENTS HOLDINGSIRONA DENTAL SYSTEMS GMBH · VDW GMBH · +2 | 417 | 2004–2026 | Pure Global AI |
| Australia | TGA | Registration holder | Dentsply Sirona Pty LtdSirona Dental Systems GmbH · MIS Implants Technologies Ltd · +2 | 373 | 2003–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MIS IMPLANTS TECHNOLOGIES LTDDENTSPLY IMPLANTS MANUFACTURING GMBH · MAILLEFER INSTRUMENTS HOLDING SÀRL · +2 | 225 | 1998–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | MIS Implants Technologies Ltd.Maillefer Instruments Holding Sarl · ZHERMACK S.p.A. · +2 | 187 | 2021–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MIS Implants Technologies Ltd.Maillefer Instruments Holding Sarl · Maillefer Instruments Holding Sàrl · +2 | 162 | — | Pure Global AI |
| China | NMPA | Registration holder | 西诺德牙科设备公司Sirona Dental Systems GmbH登士柏种植体制造公司DENTSPLY Implants Manufacturing GmbH · 德固丹特公司DeguDent GmbH · +2 | 119 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Zhermack S.p.A.Maillefer Instruments Holding Sàrl · Dentsply Sirona Orthodontics Inc. · +2 | 113 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Sirona Dental Systems GmbHMIS Implants Technologies Ltd. · OraMetrix · +2 | 96 | — | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | DENTSPLY DETREY GMBH | 90 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Maillefer Instruments Holding S.a.r.l.Wellspect HealthCare · Orametrix · +2 | 74 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MIS IMPLANTS TECHNOLOGIES LTDSIRONA DENTAL SYSTEMS GmbH · MAILLEFER INSTRUMENTS HOLDING SARL · +2 | 62 | 2003–2026 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｓｉｒｏｎａ Ｄｅｎｔａｌ Ｓｙｓｔｅｍｓ ＧｍｂＨＤｅｎｔｓｐｌｙ ＩＨ ＡＢ · ＭＩＳ Ｉｍｐｌａｎｔｓ Ｔｅｃｈｎｏｌｏｇｉｅｓ Ｌｔｄ． | 43 | 2007–2024 | Pure Global AI |
| Hong Kong | MDD | Registration holder | Dentsply Sirona Inc.Sirona Dental Systems GmbH · Maillefer Instruments Holding Sàrl · +2 | 26 | 2025–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dentsply Sirona, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Ankylos Cercon BalanceAnkylos Temporary Abutment BalanceAnti rotation cementing cap for connect abutmentAtlantis Abutment in Zirconia for 3i Certain MicroMini ImplantsC1Cercon AbutmentsConi Con Ti BaseConnect abutmentConnect abutment anti rotation temporary cylinderConnect abutment free rotation temporary cylinder 12 moreConnect abutment healing capDental Abutment/ImplantEsthetiCapFree rotation cementing cap for connect abutmentMIS C1 Narrow Platform Conical Connection Implant SystemMIS C1 Wide Platform Conical Connection AbutmentsMIS DENTAL IMPLANT SYSTEMMIS Internal Hex Dental Implant SystemMIS V3 Conical Connection Dental Implant SystemSEVEN MGuideSeven, M4, Lance ImplantsTi Base | 2008 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | C1ImplantMIS C1 Narrow Platform Conical Connection Implant SystemMIS C1 Wide Platform Conical Connection AbutmentsMIS DENTAL IMPLANT SYSTEMMIS Internal Hex Dental Implant SystemMIS Short ImplantsMIS V3 Conical Connection Dental Implant SystemPrimeTaperSEVEN MGuide 2 moreSeven, M4, Lance ImplantsXiVe TG | 2008 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | ATLANTIS CrownCeltra CeramCELTRA DuoCeltra® Duo and Cerec® Zirconia Blocks & Materials Starter KitCeramco 3Ceramco 3 C3Ceramco 3 Enamel,Ceramco ICerec Essentials Materials Starter KitCermaco II 19 moreColorlogicDentsply Sirona Universal Body StainDentsply Sirona Universal Incisal StainDentsply Sirona Universal OverglazeDentsply Sirona Universal Overglaze-High FluDentsply Sirona Universal StainDentsply Sirona Universal Stain & Overglaze KitDuceragold KissDuceram Kiss PorcelainDuceram Plus PorcelainEdge ShoulderExcelsior Porcelain,LFCQuattro Porcelain SystemUniversal Body StainUniversal Incisal StainUniversal OverglazeUniversal Overglaze-High FluUniversal Stain | 2008 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Aquasil Ulta+ Smart Wetting IMpression MaterialAquasil Ultra RigidAquasil Ultra XLVElite GlassElite HD+Elite HD+ Maxi Tray MaterialElite HD+ MonophaseElite HD+ Putty SoftElite HD+ Tray MaterialFreealgin 14 moreGENIE MAGIC MIX ULTRA HYDRHydrogum 5 AlginateHydrogum AlginateJeltrateJeltrate PlusNeocolloid AlginateOcclufast CADOcclufast RockOrthoprint AlginateRegisilReprosilSilgimix Alginate ReplacementTray AdhesiveTropicalgin Alginate | 2003 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Adaptable Composite ResinComspan CementEsthet-X Easy TwistEsthet-X Improved,Esthet-X Micro Matrix,Fluorocore IIGenios TeethPrismaPrisma Composite Polishing PasteSureFil Restorative 5 moreTooth Conditioner GelTPH Improved,TPH Spectra STTPH SpectrumTPH3 Flow, | 1992 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Lucitone Digital Print for PrimeprintPrine & Bond NT DC Nano-TechSelf-CureSelf-Cure ActivatorXeno IV | 2008 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Digital denture early experience kitLucitone Digital PrintLucitone Digital Print for Primeprint | 2007 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Bobcat PRO Ultrasonic Scaler,Cavitron JET SPS,Cavitron SPS,Focused Spray Inserts,Inserts,JetShield Assembly,Prophy Jet Air Polishing System,Prophy Jet SheathProphy-Jet PowderProUltra Endo Tips 5 moreProUltra SINE TipProUltra SurgicalSlimline InsertsSofScaleSofTip Dispos Prophy Tip | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2001 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | ProRoot MTAProRoot MTA Matl (root repair)ProRoot MTA, Tooth Colored FormulaRoot Canal Lube | 2008 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | — | 2019 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Essix (Sports) MouthguardEssix A+Essix ACEEssix C+Essix Dual LaminatesEssix Nightguard LaminateEssix PLUSEssix Tray-Rite Tray MaterialIntegrity Multi-Cure SampleMultilayer PMMA 4 moreNightguard Laminate (M);PMMA DisksShaded PMMAVIPI BLOCK | 2006 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Midwest E miniMidwest Rhino XPMidwest Shorty Single Speed Air MotorMidwest Shorty Two Speed Air MotorRhino XP | 2008 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Barricaid Perio DressingCalibra Esthetic Resin CementEsthet-X FlowFluorocore IITylok Cement | 2008 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Delton Clear Pit & FissureDelton FS+Delton Opaque Pit & Fissure SealantDelton Pit & Fissure Sealant,Delton PLUSFluorshield VLC | 2008 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | — | 2018 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Contra Angle HeadsMidwest Handpiece,Midwest RDHNUPRO revolvRhino HandpieceShorty Handpiece & Motor,Straight Attachments | 2008 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Essix (Sports) MouthguardEssix A+Essix ACEEssix C+Essix Dual LaminatesEssix Nightguard LaminateEssix PLUSEssix Tray-Rite Tray MaterialNightguard Laminate (M); | 2005 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | — | 2012 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | — | 2006 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | — | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Palodent | 2002 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | Lucitone Digital Print for Primeprint | 2019 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | SureSmile Advanced Software v 7.6SureSmile Aligner Software v 7.6SureSmile Ortho Software v 7.6 | 2018 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Caulk Post & Core KitPaper Points | 1996 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | Ossix AgileOssix BreezeOSSIX PlusOSSIX VOLUMAX | 2017 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Lucitone Digital Print for Primeprint | 2021 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | DrillsGATESLARGO | 1996 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | — | 2018 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | — | 1995 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | NUPRONUPRO Sensodyne Prophylaxis Paste with NovaMin | 1977 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | — | 1992 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | — | 1977 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | — | 2008 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Maker | — | 2019 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Essix (Sports) MouthguardEssix A+Essix ACEEssix C+Essix Dual LaminatesEssix Nightguard LaminateEssix PLUSEssix Tray-Rite Tray MaterialNightguard Laminate (M);SureSmile Aligner 3 moreSureSmile Aligner Transfer TraySureSmile AlignersSureSmile Aligners Attachment Tray | 2006 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | — | 2006 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | — | 2001 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | — | 1998 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | — | 1998 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | — | 1984 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | BondBone4BONE BCH | 2008 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | — | 2006 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Zircon diamond burr set | 1995 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | — | 1997 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | FLASHTIPSSani-Tip | 2006 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Maker | — | 2018 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | Tube Extension | 1992 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | — | 2005 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Aquasil Ultra Cordless digit Power Dispenserdigit Syringe Dispenser | 1979 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | digitHydrosilIntra Oral TipsMixing TipsOral TipsRegisilReprosilVirtual DispenserVirtual Intra Oral TipsVirtual Mixing Tips | 2000 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Bracket Height Gauge | 1977 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | — | 1992 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Dycal Calcium Hydroxide | 2008 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 1997 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | — | 1977 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | — | 1984 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Dentin Desensitizer Agent | 2008 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | — | 2025 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | OSSIX Bone | 2016 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | SureSmile Advanced SoftwareSureSmile Aligner SoftwareSureSmile Orthodontic Software | 2019 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | — | 1997 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Lister | — | 2022 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | SureSmile Wires | 1992 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Jenker Needle Stick ProtectorX-Tip Intraosseous Injection Sys | 2008 |
| Intraoral X-Ray UnitEAP · Class 2 | Dental X-ray units | Maker | — | 2018 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | — | 1987 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Adhesive Bite-Wing TabsAdhesive Comfort Tab for Film -Cover Cozee®BAI Bite-Block film holdersBAI Instrument KitsBite-Wing Bite-Blocks film holdersBite-Wing Instrument KitsBite-Wing Loops film holdersCover Cozee BWCover Cozee Comfort SolutionCover Cozee Sensor Cover Tamer 23 moreEezee-Grip® Digital Sensor HolderEndoRay® II Endodontic Film HolderFlip-RayRinn Digital Sensor CoversRinn® Cover-Cozee® Sensor Cover TamerRinn® Digital Sensor LoopsRinn® LoopsRINN® XCP-ORA®Schick CDR Elite Sensor HolderSilicone BW #2 Film HolderSnap-A-Ray® DS for SensorsSnap-A-Ray® Film HolderStabe® Disposable Film HoldersUni-Bite® Universal Film HolderUni-Grip® 360 Universal Sensor HolderUni-Grip® Universal Radiography HolderXCP-DS FIT® Sensor HolderXCP-DS® Digital Sensor Positioning KitsXCP-DS® Digital Sensor Replacement Baskets and Bite BlocksXCP-DS® Replacement BitepiecesXCP® / XCP-ORA® Film Positioning KitsXCP® Disposable Bite-Blocks (film holders)XCP®, BAI & XCP-DS® Stainless Steel Indicator Arms | 1996 |
| X-Ray Beam AlignerEHA · Class 1 | — | Maker | Uni-GRIPAR®X-Ray Exposure Alignment (XCP® / XCP-ORA®)XCP-DS® Sensor Holder | 2008 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Flex-View Interproximal StripsInterproximal Serrated Strips | 2006 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Dental Tools | 1997 |
| Amalgam AlloyEJJ · Class 2 | — | Maker | — | 2008 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | Option | 2003 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | — | 2006 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | — | 1984 |
| Preformed CrownELZ · Class 1 | — | Maker | Atlantis Temp Crown | 2006 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Lister | — | 2003 |
| Resin ApplicatorKXR · Class 1 | — | Lister | — | 1996 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | — | 2018 |
| Dental Prophylaxis KitNYC · Class 1 | Dental hand instruments | Maker | SureSmile | 2018 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | — | 2022 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | — | 2013 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | — | 1992 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | Elite MixHurrimixHurrimix 2Modulmix | 2005 |
| Articulation PaperEFH · Class 1 | — | Maker | — | 2003 |
| All Precision AttachmentEGG · Class 1 | — | Maker | AttachmentsPrecision Attachment | 2003 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | — | 2003 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | — | 1997 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | HiTrayMTM Clear Aligner Patient Case (contains only impression trays, not aligners)MTML Impression Tray PackUniversal Tray Adhesive | 1999 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | — | 2004 |
| Preformed AnchorEJX · Class 1 | — | Lister | — | 1983 |
| Endodontic Silver PointEKL · Class 1 | — | Lister | — | 2012 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | — | 1997 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Genios | 2022 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | — | 1977 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | — | 2016 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | — | 1998 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | Contra-angle | 2017 |
| AirbrushKOJ · Class 2 | — | Maker | JET-Fresh Prophy Powder | 2008 |
| Caries Detection DeviceLFC · Class 2 | Caries detection devices | Lister | — | 2012 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | — | 2025 |
| Endodontic KitNYD · Class 2 | — | Maker | — | 2022 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Orthodontic Anchor Screw | 2017 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | — | 2022 |
| Orthodontic Vibratory AccessoryOYH · Class 2 | — | Maker | — | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dentsply Sirona, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Apr 2026 | K260722 | SureSmile Aligner (ASSY500020) | NXC Sequential Aligner |
| 4 Mar 2026 | K253565 | SureSmile Software | PNN Orthodontic Software |
| 5 Feb 2026 | K253959 | Primevision 3D | OAS Dental Computed Tomography X-Ray |
| 9 Dec 2025 | K252343 | Atlantis® Abutments in Titanium | NHA Endosseous Dental Implant Abutment |
| 26 Nov 2025 | K252248 | CEREC Tessera Abutment System | NHA Endosseous Dental Implant Abutment |
| 21 Nov 2025 | K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | NHA Endosseous Dental Implant Abutment |
| 29 Aug 2025 | K250771 | Primescan 2 | NTK Light Transmission Caries Detector |
| 25 Aug 2025 | K251811 | Motor and Apex Module (MaAM) | EBW Handpiece and Cord Foot Controller |
| 21 Aug 2025 | K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | DZE Root-Form Endosseous Implant |
| 24 Jul 2025 | K251297 | MIS LYNX Conical Connection Implant System | DZE Root-Form Endosseous Implant |
| 30 Apr 2025 | K250295 | Dentsply Sirona Titanium Bases system | NHA Endosseous Dental Implant Abutment |
| 11 Apr 2025 | K250081 | Atlantis® Abutments in Titanium | NHA Endosseous Dental Implant Abutment |
| 13 Feb 2025 | K243546 | AH Plus Endodontic Sealer | KIF Root Canal Filling Resin |
| 17 Dec 2024 | K243336 | Lucitone Digital Print Denture System | EBI Rebasing Repairing Relining Denture Resin |
| 25 Nov 2024 | K241692 | MIS LYNX Conical Connection Implant System | DZE Root-Form Endosseous Implant |
| 24 Oct 2024 | K242462 | CEREC Cercon 4D CAD/CAM Blocks | EIH Porcelain Powder |
| 28 Aug 2024 | K241557 | Cercon® yo ML | EIH Porcelain Powder |
| 24 Jul 2024 | K233865 | X-Smart Pro; X-Smart Pro+ | EKX Ac-Powered Direct Drive Handpiece |
| 7 May 2024 | K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | NHA Endosseous Dental Implant Abutment |
| 2 Apr 2024 | K240888 | Calibra Abutment Resin Cement | EMA Dental Cement |
| 20 Oct 2023 | K231578 | Lucitone Digital Print Denture System | EBI Rebasing Repairing Relining Denture Resin |
| 18 Oct 2023 | K230199 | Byte Aligner System | NXC Sequential Aligner |
| 22 Mar 2023 | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2022 | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | DZE Root-Form Endosseous Implant |
| 16 Nov 2022 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | DZE Root-Form Endosseous Implant |
| 1 Apr 2022 | K213432 | MIS Angulated multi-unit abutments | NHA Endosseous Dental Implant Abutment |
| 15 Nov 2021 | K213449 | DS Implants abutments provided with the EV connection | NHA Endosseous Dental Implant Abutment |
| 27 Aug 2021 | K210610 | PrimeTaper EV Dental Implant | DZE Root-Form Endosseous Implant |
| 28 Jul 2021 | K211225 | MIS Ti-base abutment | NHA Endosseous Dental Implant Abutment |
| 17 Jun 2021 | K210886 | MIS Lance+ Conical Connection Dental Implant System | DZE Root-Form Endosseous Implant |
| 20 Jan 2021 | K202629 | Dentsply Sirona Universal Spray Glazes | EIH Porcelain Powder |
| 3 Sep 2020 | K200102 | MIS Dental Implant System | DZE Root-Form Endosseous Implant |
| 2 Sep 2020 | K193405 | Simplant Digital Guide | NDP Endosseous Dental Implant Accessories |
| 19 Aug 2020 | K200191 | Sirona Dental CAD/CAM System with InLab Software | PNP Dental Abutment Design Software for Dental Laboratory |
| 16 Aug 2020 | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | NHA Endosseous Dental Implant Abutment |
| 6 Jul 2020 | K191152 | MIS Ti-base Abutment | NHA Endosseous Dental Implant Abutment |
| 22 Jun 2020 | K201140 | Axeos | OAS Dental Computed Tomography X-Ray |
| 25 Mar 2020 | K193078 | MIS CONNECT Conical Connection System | NHA Endosseous Dental Implant Abutment |
| 5 Mar 2020 | K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | NHA Endosseous Dental Implant Abutment |
| 3 Mar 2020 | K193064 | Atlantis suprastructures | NHA Endosseous Dental Implant Abutment |
| 23 Jan 2020 | K192530 | Surefil one Self-adhesive Composite Hybrid | EMA Dental Cement |
| 13 Jan 2020 | K192409 | Midwest Rhino XE and Air Motor M | EFB Dental Air-Powered Handpiece |
| 11 Dec 2019 | K192149 | MIS Dental Implant System | DZE Root-Form Endosseous Implant |
| 20 Nov 2019 | K191865 | SmartLite Pro Modular LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 27 Sep 2019 | K190059 | CEREC Guides | NDP Endosseous Dental Implant Accessories |
| 26 Aug 2019 | K191427 | Halley resin system | EBI Rebasing Repairing Relining Denture Resin |
| 16 Jul 2019 | K191616 | Orthophos S | OAS Dental Computed Tomography X-Ray |
| 10 Jul 2019 | K183079 | Conometric Abutments | NHA Endosseous Dental Implant Abutment |
| 24 Apr 2019 | K190043 | Halley resin | EBI Rebasing Repairing Relining Denture Resin |
| 28 Jan 2019 | K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | NHA Endosseous Dental Implant Abutment |
| 18 Dec 2018 | K182422 | Lucitone Denture Base Materials | EBI Rebasing Repairing Relining Denture Resin |
| 20 Nov 2018 | K182288 | TPH Spectra ST Flowable Composite Restorative | EBF Resin Tooth Shade Material |
| 11 Oct 2018 | K181520 | Sirona Dental CAD/CAM System | NHA Endosseous Dental Implant Abutment |
| 28 Sep 2018 | K181476 | Prime&Bond active Universal Adhesive | KLE Resin Tooth Bonding Agent |
| 18 Jul 2018 | K181189 | ATLANTIS Conus Structure | NHA Endosseous Dental Implant Abutment |
| 22 Jun 2018 | K180282 | MIS Internal Hex Dental Implant System | DZE Root-Form Endosseous Implant |
| 16 Mar 2018 | K173326 | MIS CONNECT Conical Connection Abutment | NHA Endosseous Dental Implant Abutment |
| 11 Jan 2018 | K171122 | CEREC Ortho Software | PNN Orthodontic Software |
| 28 Dec 2017 | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | DZE Root-Form Endosseous Implant |
| 30 Nov 2017 | K172225 | Atlantis Abutment for MIS Implant | NHA Endosseous Dental Implant Abutment |
| 14 Aug 2017 | K163398 | ATLANTIS suprastructures | NHA Endosseous Dental Implant Abutment |
| 15 Jun 2017 | K170849 | SIMPLANT Guide | NDP Endosseous Dental Implant Accessories |
| 26 May 2017 | K163349 | MIS V3 Conical Connection Dental Implant System | DZE Root-Form Endosseous Implant |
| 31 Mar 2017 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | NHA Endosseous Dental Implant Abutment |
| 24 Feb 2017 | K162888 | Cercon | EIH Porcelain Powder |
| 10 Feb 2017 | K161213 | XSmart iQ | EBW Handpiece and Cord Foot Controller |
| 3 Feb 2017 | K163155 | MTM Clear Aligner | NXC Sequential Aligner |
| 6 Oct 2016 | K161330 | Pour Acrylic | EBI Rebasing Repairing Relining Denture Resin |
| 27 Sep 2016 | K162107 | TPH Spectra+ Universal Composite Restorative | EBF Resin Tooth Shade Material |
| 27 Sep 2016 | K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | EKX Ac-Powered Direct Drive Handpiece |
| 29 Aug 2016 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | NHA Endosseous Dental Implant Abutment |
| 26 Aug 2016 | K161030 | ATLANTIS Abutment for CONELOG implant | NHA Endosseous Dental Implant Abutment |
| 12 Aug 2016 | K161269 | CELTRA Press | EIH Porcelain Powder |
| 2 Jun 2016 | K160099 | CEREC SpeedGlaze | EIH Porcelain Powder |
| 24 Jul 2015 | K151045 | TENEO Dental Treatment Unit and Accessories | EIA Operative Dental Unit |
| 17 Jul 2015 | K150909 | INTEGO Family and Accesories | EIA Operative Dental Unit |
| 2 Jul 2015 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 8 May 2015 | K150217 | ORTHOPHOS SL | OAS Dental Computed Tomography X-Ray |
| 30 May 2014 | K131319 | T1/T2/T3 TURBINE FAMILY | EFB Dental Air-Powered Handpiece |
| 25 Oct 2013 | K130999 | OSSEOSPEED PROFILE EV | DZE Root-Form Endosseous Implant |
| 8 Apr 2013 | K123664 | INCORIS ZI | EIH Porcelain Powder |
| 20 Mar 2013 | K123952 | CEREC BLOCS C IN | EIH Porcelain Powder |
| 15 Mar 2013 | K123070 | GALILEOS FAMILY | OAS Dental Computed Tomography X-Ray |
| 1 Feb 2013 | K123545 | INCORIS TZI | EIH Porcelain Powder |
| 15 Oct 2012 | K122348 | QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW | EBI Rebasing Repairing Relining Denture Resin |
| 8 Aug 2012 | K112162 | CONICAL CONNECTION IMPLANTS | DZE Root-Form Endosseous Implant |
| 17 Feb 2012 | K111421 | SIRONA DENTAL CAD/CAM SYSTEM | NHA Endosseous Dental Implant Abutment |
| 22 Mar 2011 | K103711 | ORTHOPHOS XG 3D / CEPH | OAS Dental Computed Tomography X-Ray |
| 22 Oct 2010 | K100152 | SIRONA CAD/CAM SYSTEM | NHA Endosseous Dental Implant Abutment |
| 21 Oct 2010 | K101014 | BOND BONE | LYC Synthetic Bone Grafting Material |
| 5 Jan 2010 | K092555 | UNO NARROW IMPLANT | DZE Root-Form Endosseous Implant |
| 26 Mar 2009 | K083739 | HYDRORISE AND HYDROSYSTEM | ELW Impression Material |
| 23 Dec 2008 | K083344 | HELIODENT PLUS | EHD Extraoral with Timer X-Ray Unit |
| 26 Aug 2008 | K081903 | XIOS PLUS WALL-MODULE | MUH Digital Extraoral Source X-Ray System |
| 14 May 2008 | K081084 | COLORISE RIGID | ELW Impression Material |
| 22 Apr 2008 | K080162 | UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 11 Apr 2008 | K080882 | CEREC OPTI SPRAY | ELW Impression Material |
| 14 Mar 2008 | K080130 | OCCLUFAST CAD | ELW Impression Material |
| 14 Feb 2008 | K072107 | PERIOSCAN, MODEL: D 3496 | ELC Ultrasonic Scaler |
| 25 Jan 2008 | K073461 | ORTHO ANCHOR SCREWS | OAT Orthodontic Endosseous Implant |
| 12 Dec 2007 | K073005 | ELITE GLASS | ELW Impression Material |
| 11 May 2007 | K070677 | COLORISE | ELW Impression Material |
| 25 Apr 2007 | K070700 | FREEALGIN | ELW Impression Material |
| 20 Apr 2007 | K070022 | MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 | DZE Root-Form Endosseous Implant |
| 12 Sep 2006 | K062509 | INCORIS ZI | EIH Porcelain Powder |
| 8 Sep 2006 | K062506 | INCORIS AL | EIH Porcelain Powder |
| 14 Apr 2006 | K060892 | GALILEOS | MUH Digital Extraoral Source X-Ray System |
| 31 Mar 2006 | K052515 | SIROENDO | EKX Ac-Powered Direct Drive Handpiece |
| 1 Mar 2006 | K053619 | COLORBITE | ELW Impression Material |
| 6 Sep 2005 | K051661 | IMPLANT HANDPIECES | EKX Ac-Powered Direct Drive Handpiece |
| 19 Jul 2005 | K050417 | ELITE IMPLANT | ELW Impression Material |
| 15 Jul 2005 | K051424 | HYDROGUM 5 | ELW Impression Material |
| 21 Mar 2005 | K050354 | PERIOSCAN ULTRASONIC SCALER | ELC Ultrasonic Scaler |
| 24 Jan 2005 | K043118 | HYDROGUM SOFT | ELW Impression Material |
| 15 Dec 2004 | K043131 | TORPICALGIN | ELW Impression Material |
| 23 Feb 2004 | K033812 | SIROAIR L AIR SCALER | EFB Dental Air-Powered Handpiece |
| 15 Jan 2004 | K033675 | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER | KOJ Airbrush |
| 12 Dec 2003 | K033640 | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS | ELC Ultrasonic Scaler |
| 14 Nov 2003 | K032543 | SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES | EIA Operative Dental Unit |
| 10 Oct 2003 | K033073 | ORTHOPHOS XG DS/CEPH | EHD Extraoral with Timer X-Ray Unit |
| 19 Aug 2003 | K031584 | SIROTORQUE L | EBW Handpiece and Cord Foot Controller |
| 18 Dec 2002 | K024041 | ZETAPLUS SOFT | ELW Impression Material |
| 18 Dec 2002 | K024034 | OCCLUFAST ROCK | ELW Impression Material |
| 28 Oct 2002 | K022653 | ELITE MONOPHASE | ELW Impression Material |
| 6 Dec 2001 | K013659 | MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 6 Dec 2001 | K013650 | ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD | MUH Digital Extraoral Source X-Ray System |
| 1 Nov 2001 | K012517 | CEREC3 VITABLOCKS | ELW Impression Material |
| 28 Sep 2001 | K003191 | MIS IMPLANT SYSTEM DECIVE | DZE Root-Form Endosseous Implant |
| 16 Nov 2000 | K002620 | SURESMILE SYSTEM | EIA Operative Dental Unit |
| 2 May 2000 | K000672 | HELIODENT VARIO | EHD Extraoral with Timer X-Ray Unit |
| 8 Feb 2000 | K994172 | CEREC 3 | ELW Impression Material |
| 23 Aug 1999 | K992644 | SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 30 Apr 1999 | K990528 | ORTHOPHOS 3/3 CEPH/3 DS | MUH Digital Extraoral Source X-Ray System |
| 11 Dec 1998 | K983242 | SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES | EIA Operative Dental Unit |
| 22 Oct 1998 | K983057 | ORTHOPHOS 5/PLUS/CD | MUH Digital Extraoral Source X-Ray System |
| 21 May 1998 | K981091 | NEOCOLLOID, ORTHOPRINT | ELW Impression Material |
| 29 Jan 1998 | K974704 | HYDROGUM | ELW Impression Material |
| 1 Aug 1997 | K972239 | ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING | ELW Impression Material |
| 16 Jul 1997 | K972027 | ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) | ELW Impression Material |
| 21 Mar 1997 | K970134 | THERMAPREP PLUS OVEN | EKM Gutta-Percha |
| 10 Feb 1997 | K964174 | MINERAL TRIOXIDE AGGREGATE (MTA) | KIF Root Canal Filling Resin |
| 14 Nov 1996 | K963609 | PHASE PLUS | ELW Impression Material |
| 16 Jan 1996 | K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | DZA Intraoral Dental Drill |
| 26 May 1994 | K922931 | THERMAPOST ENDODONTIC ROOT CANAL POST | ELR Root Canal Post |
| 20 Oct 1993 | K933582 | PROFILE SERIES 29 FILES | EKS Endodontic Pulp Canal File |
| 29 Mar 1991 | K910224 | THERMAPREP | EKM Gutta-Percha |
| 13 Nov 1990 | K900986 | THERMAFIL ENDODONTIC OBTURATOR | EKM Gutta-Percha |
| 7 Apr 1988 | K881139 | THERMAFIL ENDODONTIC OBTURATOR | EKM Gutta-Percha |
Some of these clearances are listed with FDA today by another company: Ivoclar Vivadent, AG (5), Ultradent Products, Inc. (4), A-dec, Inc. (3), Institut Straumann AG (2), Den-Mat Holdings, LLC (1), VANNINI DENTAL INDUSTRY S.r.l. (1).
Also lists devices cleared under other names
Dentsply Sirona, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentsply Intl., Inc. (55), Dentsply International, Inc. (25), Astra Tech AB (23), Friadent GmbH (9), Atlantis Components, Inc. (8), Datum Dental, Ltd. (5), Pulpdent Corporation (5), Johnson & Johnson Professionals, Inc. (5).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Oct 2026 | K262415 | OSSIX Plus | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 10 Dec 2024 | K242025 | Elos Accurate® Hybrid Base | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 18 Jul 2022 | K212509 | OSSIX Breeze | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 24 Feb 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | EKX Ac-Powered Direct Drive Handpiece |
| 27 Oct 2020 | K200273 | FREEPRINT temp | Detax GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 1 Nov 2019 | K183018 | VPro5 | Propel Orthodontics, LLC | OYH Orthodontic Vibratory Accessory |
| 1 Aug 2018 | K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | EIH Porcelain Powder |
| 26 Feb 2018 | K170175 | ENDOSEAL MTA | Maruchi | KIF Root Canal Filling Resin |
| 5 Jan 2018 | K171860 | Sureclear aligners | Emergo Global Consulting, LLC | NXC Sequential Aligner |
| 18 Jul 2017 | K163714 | OSSIX BONE | Datum Dental, Ltd. | NPM Animal Source Bone Grafting Material |
| 9 Feb 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 23 Nov 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Bürmoos GmbH | EBW Handpiece and Cord Foot Controller |
| 4 Aug 2016 | K153549 | OSSIX VOLUMAX | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 4 Aug 2016 | K160281 | OSSIX PLUS | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 4 Mar 2016 | K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | ELW Impression Material |
| 29 Jan 2016 | K152247 | ATLANTIS Crown | Dentsply International, Inc. | EIH Porcelain Powder |
| 30 Oct 2015 | K151619 | Prime&Bond Elect Universal Dental Adhesive | Dentsply International, Inc. | KLE Resin Tooth Bonding Agent |
| 16 Jun 2015 | K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | ELC Ultrasonic Scaler |
| 26 Feb 2015 | K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Dentsply International, Inc. | KIF Root Canal Filling Resin |
| 24 Nov 2014 | K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 20 Aug 2014 | K140347 | ANKYLOS C/X IMPLANT SYSTEM | Dentsply Intl., Inc. | DZE Root-Form Endosseous Implant |
| 16 Jul 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 22 Jan 2014 | K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | Dentsply International, Inc. | NHA Endosseous Dental Implant Abutment |
| 23 Jul 2013 | K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | Dentsply Intl., Inc. | ELC Ultrasonic Scaler |
| 1 May 2013 | K130216 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT | Dentsply Implant | NHA Endosseous Dental Implant Abutment |
| 22 Feb 2013 | K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | Dentsply Intl., Inc. | EIH Porcelain Powder |
| 23 Jan 2013 | K121810 | OSSEOSPEED ANGLED ABUTMENT EV | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 11 Dec 2012 | K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS | Dentsply International, Inc. | NHA Endosseous Dental Implant Abutment |
| 15 Oct 2012 | K122331 | CAVITY VARNISH | Dentsply International, Inc. | LBH Cavity Varnish |
| 6 Aug 2012 | K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | EJR Oral Cavity Abrasive Polishing Agent |
| 31 Jul 2012 | K120414 | OSSEOSPEED PLUS | Astra Tech AB | DZE Root-Form Endosseous Implant |
| 5 Jul 2012 | K120338 | ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 1 Mar 2012 | K113003 | ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 13 Feb 2012 | K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | Dentsply International, Inc. | ELW Impression Material |
| 28 Dec 2011 | K113040 | CERAMIR CROWN & BRIDGE | Doxa Dental AB | EMA Dental Cement |
| 1 Dec 2011 | K112138 | ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 9 Nov 2011 | K112152 | CERCON HT | Dentsply International, Inc. | EIH Porcelain Powder |
| 15 Sep 2011 | K103089 | SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS | Mis - Implant Technologies , Ltd. | DZE Root-Form Endosseous Implant |
| 21 Jun 2011 | K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 10 Jun 2011 | K110356 | ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 10 Jun 2011 | K110640 | ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 20 Apr 2011 | K110768 | COMPUTED DENTAL RADIOGRAPHY | Schick Technologies, Inc. | MUH Digital Extraoral Source X-Ray System |
| 23 Feb 2011 | K101732 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | DZE Root-Form Endosseous Implant |
| 3 Feb 2011 | K103020 | ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 16 Dec 2010 | K102341 | VIPI BLOCK | Vipi Industria,Comercio,Exportacao E Importacao DE | EBG Resin Temporary Crown and Bridge |
| 8 Dec 2010 | K102739 | HYDROCOLOR 5 | Cascades Device Consulting Associates | ELW Impression Material |
| 28 Sep 2010 | K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 11 Aug 2010 | K102128 | VITABLOCS | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH Porcelain Powder |
| 16 Apr 2010 | K093780 | ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 22 Dec 2009 | K093483 | ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 30 Nov 2009 | K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | EAP Intraoral X-Ray Unit |
| 28 Sep 2009 | K091920 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 28 Aug 2009 | K091706 | QUATTRO PORCELAIN SYSTEM | Dentsply International, Inc. | EIH Porcelain Powder |
| 22 May 2009 | K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM | Dentsply Intl., Inc. | DZE Root-Form Endosseous Implant |
| 15 Apr 2009 | K083871 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 14 Apr 2009 | K083841 | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL | Dentsply International, Inc. | EBF Resin Tooth Shade Material |
| 10 Feb 2009 | K083326 | FLUOROCORE 2 | Dentsply International, Inc. | EBF Resin Tooth Shade Material |
| 17 Sep 2008 | K080156 | OSSEOSPEED TM PROFILE SYSTEM | Astra Tech AB | DZE Root-Form Endosseous Implant |
| 29 Jul 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | KMW Rotary Bone Cutting Handpiece |
| 30 Apr 2008 | K080396 | OSSEOSPEED NARROW | Astra Tech AB | DZE Root-Form Endosseous Implant |
| 27 Mar 2008 | K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | Dentsply Intl., Inc. | NHA Endosseous Dental Implant Abutment |
| 29 Feb 2008 | K073540 | ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 15 Feb 2008 | K073067 | ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS | Dentsply International, Inc. | DZE Root-Form Endosseous Implant |
| 12 Feb 2008 | K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE | Dentsply International, Inc. | NHA Endosseous Dental Implant Abutment |
| 4 Feb 2008 | K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | Coltene/Whaledent AG | EFB Dental Air-Powered Handpiece |
| 23 Jan 2008 | K073173 | SELF-ADHESIVE RESIN CEMENT | Dentsply Interntional | EMA Dental Cement |
| 19 Dec 2007 | K073117 | DENTIN DESENSITIZER AGENT | Dentsply Intl., Inc. | LBH Cavity Varnish |
| 16 Nov 2007 | K072483 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 2 Nov 2007 | K072134 | SCHICK COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | MUH Digital Extraoral Source X-Ray System |
| 12 Oct 2007 | K072713 | ION DENTAL RESIN SYSTEM | Dentsply International, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 5 Oct 2007 | K071946 | ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 1 Oct 2007 | K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 13 Sep 2007 | K071891 | STATIS DENTAL HANDPIECES | Coltene/Whaledent AG | EFB Dental Air-Powered Handpiece |
| 27 Apr 2007 | K063779 | OSSEOSPEED 4.0S-6MM, MODEL 24619 | Astra Tech AB | DZE Root-Form Endosseous Implant |
| 14 Mar 2007 | K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | Dentsply Intl., Inc. | KLE Resin Tooth Bonding Agent |
| 2 Mar 2007 | K063734 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 20 Dec 2006 | K062277 | ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 19 Oct 2006 | K062418 | K-SPRAY, MODEL 085-2715 | Coltene/Whaledent AG | EFB Dental Air-Powered Handpiece |
| 25 Aug 2006 | K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | J. Morita USA, Inc. | EFA Dental Belt and/or Gear Driven Handpiece |
| 3 May 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 24 Mar 2006 | K053384 | FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | DZE Root-Form Endosseous Implant |
| 3 Mar 2006 | K053450 | ATLANTIS ABUTMENT FOR ZIMMER INTERFACE | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 20 Oct 2005 | K052409 | SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL | Sultan Chemists, Inc. | ELW Impression Material |
| 14 Oct 2005 | K052070 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA | Atlantis Components, Inc. | NHA Endosseous Dental Implant Abutment |
| 16 Sep 2005 | K051885 | MBCP | Biomatlante | LYC Synthetic Bone Grafting Material |
| 2 Sep 2005 | K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | Dentsply Intl., Inc. | ELC Ultrasonic Scaler |
| 12 Jul 2005 | K051463 | XENO ADHESIVE WITH ACTIVATOR | Dentsply Intl., Inc. | KLE Resin Tooth Bonding Agent |
| 24 Jun 2005 | K051462 | MODIFICATION TO: CERCON BASE | Dentsply Intl., Inc. | EIH Porcelain Powder |
| 14 Jun 2005 | K050208 | FRIADENT ESTHETICAP | Dentsply International, Inc. | NHA Endosseous Dental Implant Abutment |
| 22 Apr 2005 | K050880 | DYRACT EXTRA RESTORATIVE | Dentsply Intl., Inc. | EBF Resin Tooth Shade Material |
| 23 Feb 2005 | K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply International, Inc. | KLE Resin Tooth Bonding Agent |
| 18 Feb 2005 | K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL | Sultan Chemists, Inc. | ELW Impression Material |
| 26 Aug 2004 | K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | Friadent GmbH | DZE Root-Form Endosseous Implant |
| 24 Jun 2004 | K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT | Dentsply International, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 16 Jun 2004 | K040906 | CALIBRA CEMENT | Dentsply Intl., Inc. | EMA Dental Cement |
| 16 Jun 2004 | K041343 | XENO NM LIGHT CURED DENTAL ADHESIVE | Dentsply International, Inc. | KLE Resin Tooth Bonding Agent |
| 9 Jun 2004 | K040807 | MIS DENTAL IMPLANT SYSTEM | Mis - Implant Technologies , Ltd. | DZE Root-Form Endosseous Implant |
| 28 Apr 2004 | K040808 | MINI L.E.D. OEM MODULE | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 1 Apr 2004 | K040144 | QUIXX POSTERIOR RESTORATIVE | Dentsply International, Inc. | EBF Resin Tooth Shade Material |
| 18 Mar 2004 | K040421 | DUCERAGOLD PORCELAINS | Dentsply Intl., Inc. | EIH Porcelain Powder |
| 18 Mar 2004 | K040420 | DUCERAM PLUS CERAMIC SYSTEM | Dentsply Intl., Inc. | EIH Porcelain Powder |
| 4 Dec 2003 | K033705 | BOBCAT PRO SCALER SYSTEM, MODEL G-130 | Dentsply International, Inc. | ELC Ultrasonic Scaler |
| 2 Oct 2003 | K032302 | XIVE TG ABUTMENTS | Friadent GmbH | DZE Root-Form Endosseous Implant |
| 12 Aug 2003 | K030639 | XIVE 3.0 DENTAL IMPLANT SYSTEM | Friandent GmbH | DZE Root-Form Endosseous Implant |
| 14 Apr 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 9 Apr 2003 | K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL | Sultan Chemists, Inc. | ELW Impression Material |
| 3 Mar 2003 | K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM | Friadent GmbH | DZE Root-Form Endosseous Implant |
| 7 Feb 2003 | K030111 | DIAMONDCOAT ULTRASONIC INSERTS | Dentsply International, Inc. | ELC Ultrasonic Scaler |
| 7 Nov 2002 | K023631 | ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS | Astra Tech AB | NHA Endosseous Dental Implant Abutment |
| 6 Nov 2002 | K023697 | STERI-MATE STERILIZABLE HANDPIECE | Dentsply International, Inc. | ELC Ultrasonic Scaler |
| 6 Sep 2002 | K022796 | CERCON CERAM S PORCELAIN | Dentsply Intl., Inc. | EIH Porcelain Powder |
| 2 Jul 2002 | K021318 | XIVE DENTAL IMPLANT SYSTEM | Friadent GmbH | DZE Root-Form Endosseous Implant |
| 13 May 2002 | K021416 | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. | ELW Impression Material |
| 10 May 2002 | K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. | ELW Impression Material |
| 8 May 2002 | K021410 | AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. | ELW Impression Material |
| 9 Apr 2002 | K013067 | FRIALOC DENTAL IMPLANT SYSTEM | Friadent GmbH | DZE Root-Form Endosseous Implant |
| 15 Mar 2002 | K014188 | NEW PROPHY POWDER | Dentsply Intl., Inc. | KOJ Airbrush |
| 15 Mar 2002 | K013867 | XIVE DENTAL IMPLANT SYSTEM | Friadent GmbH | DZE Root-Form Endosseous Implant |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 20 Dec 2001 | K013438 | FRIALIT-2 ESTHETICBASE ABUTMENT | Friadent GmbH | DZE Root-Form Endosseous Implant |
Showing the 120 most recent of 199.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DEGUDENT GMBHFDA reg. 9681199 | HANAU Hesse, Germany | Contract manufacturer, Foreign exporter, Manufacturer, Specification developer |
| DEGUDENT GMBHFDA reg. 9612618 | Rosbach V.D.H. Hesse, Germany | Contract manufacturer |
| DENTSPLY DENTAL (TIANJIN) CO., LTD.FDA reg. 3000303964 | TEDA Tianjin, China | Contract manufacturer |
| DENTSPLY DETREY GmbHFDA reg. 8010638 | KONSTANZ Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Repacker / relabeler |
| Dentsply IH ABFDA reg. 9612468 | MOLNDAL Vastra Gotaland, Sweden | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler, Specification developer |
| DENTSPLY IH BVFDA reg. 3011824442 | Sevenum Limburg, Netherlands | Foreign exporter |
| DENTSPLY IH Inc.FDA reg. 1222802 | Waltham, MA, United States | Contract manufacturer, Manufacturer |
| Dentsply Implants Manufacturing GmbHFDA reg. 3013111692 | Hanau Hesse, Germany | Contract manufacturer |
| DENTSPLY Implants N.V.FDA reg. 3007362683 | Hasselt Limburg, Belgium | Manufacturer, Specification developer |
| DENTSPLY INDUSTRIA E COMERCIO LTDAFDA reg. 8040288 | PIRASSUNUNGA Sao Paulo, Brazil | Contract manufacturer |
| DENTSPLY INDUSTRIA E COMERCIO LTDAFDA reg. 3003756493 | PIRASSUNUNGA Sao Paulo, Brazil | Contract manufacturer, Manufacturer |
| DENTSPLY LLCFDA reg. 2424472 | York, PA, United States | Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer, Specification developer |
| DENTSPLY LLCFDA reg. 2515379 | MILFORD, DE, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| DENTSPLY NORTH AMERICA LLCFDA reg. 3006186796 | Lancaster, PA, United States | Repacker / relabeler |
| DENTSPLY SIRONA INCFDA reg. 3004884150 | York, PA, United States | Complaint file establishment |
| Dentsply Sirona Orthodontics Inc.FDA reg. 1036212 | Sarasota, FL, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| Dentsply Sirona Orthodontics Inc.FDA reg. 1649995 | RICHARDSON, TX, United States | Specification developer |
| DS REP B.V.FDA reg. 2647456 | Las Piedras, PR, United States | Contract manufacturer |
| MAILLEFER INSTRUMENTS HOLDING SARLFDA reg. 8031010 | BALLAIGUES Vaud, Switzerland | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler, Specification developer |
| MIS Implants Technologies Ltd.FDA reg. 3004203816 | BAR LEV INDUSTRIAL PARK Northern, Israel | Contract manufacturer, Foreign exporter, Manufacturer |
| OraMetrix GmbHFDA reg. 3003136642 | Berlin Brandenburg, Germany | Contract manufacturer |
| Orthodental S.A. de C.V.FDA reg. 3017619720 | Mexicali Baja California, Mexico | Contract manufacturer |
| RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)FDA reg. 3001226627 | ST. EGREVE Isere, France | Contract manufacturer, Manufacturer, Specification developer |
| Sirona Dental Systems GmbHFDA reg. 9681851 | Bensheim Hesse, Germany | Specification developer |
| SIRONA DENTAL SYSTEMS GMBHFDA reg. 9614977 | BENSHEIM Hesse, Germany | Complaint file establishment, Foreign exporter, Manufacturer, Repacker / relabeler, Specification developer |
| TULSA DENTAL PRODUCTS LLCFDA reg. 2320721 | Johnson City, TN, United States | Manufacturer, Repacker / relabeler, Specification developer |
| VDW GMBHFDA reg. 9611053 | MUNICH Bavaria, Germany | Manufacturer, Repacker / relabeler |
| Wellspect HealthcareFDA reg. 3009632672 | Molndal Vastra Gotaland, Sweden | Contract sterilizer |
| Zetta25 AGFDA reg. 3029904428 | Zurich, Switzerland | Manufacturer |
| ZHERMACK S.P.A.FDA reg. 9614794 | BADIA POLESINE (RO) Rovigo, Italy | Contract manufacturer, Manufacturer, Specification developer |
Other names on FDA records
DENTSPLY Implants Manufacturing GmbH · MIS Implants Technologies Ltd. · Orametrix · Recherches Techniques Dentaires (R.T.D.) · Sirona Dental Systems GmbH · Tulsa Dental Products LLC · Zhermack SpA · Dentsply IH AB · DeguDent GmbH · Dentsply Detrey GmbH · Dentsply Sirona Orthodontics Inc. · Maillefer Instruments Holding S.a.r.l.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2511302). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.