Manufacturer registered with FDA
Sybron Dental Specialties
Pomona, CA, United States. Lists 92 dental device types with FDA across 17 registered establishments, and holds 203 510(k) clearances as applicant.
- Device types listed
- 92
- Brands and models
- 575
- 510(k) clearances
- 2031978–2026
- Markets registered in
- 179,670 registrations outside the US
- Establishments
- 17China, Costa Rica, Czechia +3
510(k) clearances per year, 1976–2026
Registered in 17 markets
Where regulators' registries name Sybron Dental Specialties 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 | Sybron Dental Specialties | 203 clearances | 1978–2026 | Below |
| European Union | EUDAMED | Manufacturer | Ormco CorporationKERR ITALIA SRL · SpofaDental a.s. · +1 | 5,805 | — | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | SDS DE MEXICO, S. DE R.L. DE C.V.ORMCO CORPORATION | 1,671 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | KERR ITALIA S.R.LKERR CORPORATION · ORMCO CORPORATION · +2 | 713 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KERR CORPORATIONORMCO CORPORATION · Kerr Italia S.r.l. · +2 | 250 | 2004–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Ormco CorporationSpofaDental a.s. · Kerr Italia S.r.l. · +2 | 209 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Ormco CorporationOrmco Corp. · SDS de Mexico S. de R.L. de C.V. · +2 | 192 | 1998–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | ALLESEE ORTHODONTIC APPLIANCES, INC.KERR ITALIA S.R.L. · ORMCO CORPORATION · +1 | 189 | 1999–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | ORMCO CorporationKerr Corporation · Ormco Corporation · +2 | 114 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ORMCO CORPORATIONKerr Italia S.R.L · SDS de México S. de R.L. de C.V. · +2 | 105 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Kerr Italia SrlOrmco Pty Ltd · Ormco Corporation · +2 | 92 | 2004–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Kerr Italia S.r.l.Ormco Corporation · SpofaDental a.s. · +1 | 78 | 2023–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Kerr Italia S.r.l.SpofaDental a.s. · Metrex Research LLC | 71 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ORMCO CORPORATIONKERR ITALIA S.R.L. · KERR CORPORATION · +1 | 67 | 2002–2026 | Pure Global AI |
| China | NMPA | Registration holder | 奥美科公司Ormco CorporationKerr Italia S.r.l. 科尔（意大利）公司 · 科尔公司Kerr Corporation · +2 | 60 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KERR CORPORATIONORMCO CORPORATION · KERR ITALIA S.R.L. · +2 | 50 | 2011–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Kerr Italia S.r.l.Kerr Italia, S.r.l. | 4 | 2026–2026 | 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 Sybron Dental Specialties currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | AlertAlert Condensable CompositeArtiste Nano CompositeBuild-It FRBuild-It Light Cure MaterialCervicalConstruct ResinCoreRestore2Dispensing TipsFlow-It ALC 33 moreFusioHarmonize CompositeHarmonize Super clearHerculite UltraHerculite XRVHerculite XRV UltraHerculite XRV Ultra FlowKolor+ PlusNeoFilNX3 Try-In GelsOpaque Dual Cure ResinOptiguardOptiShade Bleach WhitePoint 4Point 4 TransparentPremisePremise FlowablePremise Indirect Facial DentinPremise Indirect IncisalPremise Indirect Primary DentinRevolution Formula 2SilaneSilane PrimerSimile CompositeSimpliShade Bleach WhiteSimpliShade BulkFillSimpliShade BulkFill FlowSimpliShade CompositeSimpliShade Self-Adhesive FlowSonicFill 2SonicFill 3SonicFill Handpiece, MULTIFlex Coupling, Lubrication SprayVertise Flow | 2007 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Biosplint AdhesiveBond 1 SFBond-1 Dual Cure ActivatorBond-1 Primer & AdhesiveBond-1 SF Solvent-Free SE AdhesiveBond-It Dual-Cure ActivatorBond-It Enamel/Dentin Bonding SystemBond-It PrimerEtching GelOptiBond All-In-One 10 moreOptiBond eXTRa UniversalOptiBond FLOptiBond Gel EtchantOptiBond Solo PlusOptiBond UniversalOptiBond Universal 360Optibond XTRSilaneSilane Primer37% Phosphoric Acid Etching Gel | 2009 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | AlgiNotCorrect PlusCorrect QuickCorrect V.P.S.Correct VPS PuttyExtrudeGingiBRAID+ Aluminum Potassium Sulfate Retraction CordGingiBRAID+ ShortCut Aluminum Potassium Sulfate Retraction CordGingiKNIT+ Aluminum Potassium Sulfate Retraction CordIdentic 14 moreImage Alginate Dental Impression MaterialsImage AlignateImpression CompoundIntegraKromaFazePermlasticPermlastic AdhesiveTake 1 AdvancedTake 1 Advanced BiteTake 1 Advanced PuttyTake 1 Advanced Rigid TrayTake 1 Hydro BiteUniBRAID+ Aluminum Potassium Sulfate Retraction CordVPS Adhesive | 2010 |
| Dental CementEMA · Class 2 | Dental cements | Maker | BreezeBreeze RMGIBreeze Self-Adhesive Resin CementCement-ItMaxcem EliteMaxcem Elite ChromaMojoMojo Try-In GelsNexus NX3Nexus RMGI 11 moreNexus UniversalNexus Universal ChromaNX3NX3 ClearNX3 Nexus Third GenerationTemp-Bond NETempBond Clear with TriclosanTempSpan TransparentTempSpan Transparent Temporary CementZoneZoneFree | 2006 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | — | 2007 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Red, White, & Blue RetainerSIMPLI5Spark Clear Aligner System | 2006 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | — | 2002 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | — | 2009 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | — | 2007 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | — | 2007 |
| Pulp TesterEAT · Class 2 | — | Maker | Apex LocatorBuchanan System B PluggerElements Diagnostic UnitHot Pulp Test TipSpoon TipSystem BTouch N HeatTouch N Heat CarrierTouch N Heat PluggerVitality Scanner 1 moreVitality Scanner Tip | 2007 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | GUARDIAN SEALSimpliShade Self-Adhesive FlowSonicFill 2SonicFill 3Vertise Flow | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | ConstructFill-InModeling ResinTemphaseTempSpan C&BTempSpan Dual-Cure Temporary Crown & Bridge Material | 2007 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | Pulp Canal SealerPulp Canal Sealer EWTSealapexSealapex XpressTubli-SealTubli-Seal EWTTubli-Seal EWT XpressTubli-Seal XpressZenSeal Bioceramic Root Canal SealerZenSeal Disposable Tips 1 moreZenSeal Pro Bio Ceramic Root Canal Sealer | 2016 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | — | 2023 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | — | 1982 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | Spark Clear Aligner System | 2021 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | — | 2002 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Adapt LuciwedgeBlue Cervical FoilsBlue Cervical MatricesBlue Transparent Molar & Premolar BandsBlue View Grip StripsCervical Foil & PosteriorComposite Filling SpatulaComposite InstrumentsCure-Thru Cervical FoilsCurette 20 moreDispensing GunDouble PluggerExplorerExtruderHand PluggerHawe Contoured Tofflemire BandHawe Interdental WedgesHawe Steel BandHawe Tofflemire MatricesLuciwedgeMetaFixPerforation RepairProphy ClipSingle-Dose Dispensing GunStop StripsSuperCap Matrices & SpoolsSuperMatTCF-HolderTransparent Cervical Foils & MatricesUnidose Gun | 2005 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Lythos | 2013 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Demi Plus, Light GuidesDemi ProDemi Ultra | 2011 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | EndoRingSimpliCore Universal VerifierSimpliCore Verifier for Zenflex One | 2003 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Autofit Backfill Gutta PerchaAutofit Gutta PerchaElements Gutta Percha CartridgeGutta PerchaGutta Percha CartridgeK3 Gutta PerchaK3XF Gutta PerchaSimpliCore Obturator for Zenflex OneSimpliCore Obturator UniversalSimpliFill Apical Plugs 8 moreSoftCoreTF Adaptive Gutta PerchaTF Adaptive ObturatorTF Adaptive VerifiersTF Gutta PerchaTip Snip- GP Gauge Wheel with StandZenFlex ONE Gutta PerchaZenflex Pre-Tip Gutta Percha | 2001 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Buchanan Hand PluggerCondensorelements ICElements Obturation CartridgeElements Obturation UnitHeat PluggerPacMac | 1996 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | FibreKleer 4xFibreKleer 4x Fiber PostFibreKleer PostFibreKor Fiber PostFibreKor Post | 1989 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | — | 2003 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 1996 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | — | 1978 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | — | 1982 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | — | 1982 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Clear Impression TraysOriginate Impression TraysPutty SpacerThree-In-One Impression TraysWater Cooled Impression Tray | 1977 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | All Ceramic Logic SetAll-Purpose Esthetic Logic SetAxis Carbide BursBarbed BroachesBluWhite CarbidesBur BlockCarbide BursComprehensive Universal Cutter Logic SetCrown Removal Logic SetE$D Sample Logic Set 24 moreEndodontic Access Logic SetFibreKleer 4X Fiber Post DrillFibreKor Fiber Post DrillGrayGates IPR Logic SetHawe Jet CarbidesJet CarbidesKerr CarbidesLA AxxessLowe Crown & Bridge Logic SetLVI Aesthetic Inlay/Onlay Logic SetMelker Root Shaping Logic SetMW Series Finishing Logic SetNTI Soft Tissue TrimmerPersonalized Logic SetPost DrillsPosterior Composite Logic SetR.A.P.T.O.R. Resin Sculpting Logic SetRazorT&F CarbidesTDF Carbide Logic SetTDF SeriesTDF Series Composite Logic SetTri-fissureVylon Resources Logic Set | 1993 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Autofit Paper PointsK3/K3XF Paper PointsPAPER POINTSTF Adaptive Paper PointsTF Paper PointsZenFlex ONE Paper Points | 2005 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | Pulp CanalReamers | 2003 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Ultrasonic Diamond TipUltrasonic Tips | 2007 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | EmbonteTemp-Bond Original | 2006 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | — | 1982 |
| Resin ApplicatorKXR · Class 1 | — | Maker | BrushesDisposable Applicators | 2008 |
| Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain ReliefMZW · Class 2 | — | Maker | Maxcem Elite | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2007 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | All Ceramic Logic SetAnterior Composite Logic SetAxial Reduction - MADCAxial Reduction Logic SetAxis Diamond BursBambino DiamondsBelvedere C.C.V. Logic SetBluWhiteBruxZir Logic SetCEREC Intra-Oral Art & Passion Logic Set 35 moreCEREC Prep & Finish Logic SetCEREC Prep N' Glaze Logic SetCEREC Starter Logic Setcerecdoctors.com Logic SetChamfer Preparation Logic SetComposite Logic SetGuide Pin DiamondHornbrook Finish Logic SetHornbrool Prep Logic SetIntensiv ProxoShape Diamond FileKS SeriesLA AxxessLaminate Veneer Logic SetLAVA Preparation Logic SetLogic SetLVI Anterior Direct Ressin Preparation Logic SetLVI Esthetic Preparation Logic SetModified Shoulder Logic SetNano DiamondsNano Prep Diamond Logic SetPersonalized Logic SetR.A.P.T.O.R. DiamondRadz & Soileau RSVP Logic SetRaintree Essix Logic SetReverse Preparation Logic SetSimpliCut Pre-Sterile Diamond BursTDF Diamond Logic SetTDF SeriesTDF Series Composite Logic SetTurbo Chamfer Preparation Logic SetTurbo DiamondsVeneer Preparation Logic SetZir-Cut DDS Adjusting Logic SetZIR-CUT DiamondZir-CUT Substructure Logic Set | 2014 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | elements e-motion | 2019 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | — | 2003 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | CLAMPWIRE ORTHODONTIC | 1982 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | — | 1982 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | — | 1982 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Composite Surface TreatmentOptiDisc | 1996 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Acrylic Adjustment Logic SetAXIS Laminate Veneer SetBite Adjustment Logic SetCera-Glaze Ultimate Porcelain Logic SetCeraGlaze Intra-Oral Polishing Logic SetCeraGlaze Porcelain Lab Logic SetCeraGlaze Porcelain Polishing Logic SetClinical CAD/CAM Preparation Logic SetCOMPOSITE GlanzpoliererCOMPOSITE Polishers & Prepolishers 63 moreCOMPOSITE VorpoliererDiaGloss Polishing Logic SetDIAMOND COMPOSITE PolishersE4D Chairside Dental Designer Logic SetE4D Preparation Logic SetE4D Sdjust & Polish Logic SetGlossPlus Polisher CupGOLD/ AMALGAM / PRECIOUS METAL PolishersGoldstar Gold Polishing Logic SetHawe Bristle BrushesHawe Polishing Assorted KitHiLuster Plus Polisher cupHiLusterPlus AssortmentIDF Rec.Gloss Polishers CupIDF Rec.Gloss Polishers DiscIDF Rec.Gloss Polishers FlameIDF Rec.Gloss Polishers MiniIDF Rec.HiLuster Dia PolishersInterdental WedgesMINIDENTOFLEX -COMPOSITE Polishers & PrepolishersMINIDENTOFLEX Right Angle MandrelNTI Acrylic PolisherNTI Brown AbrasiveNTI CeraGlazeNTI DiaGloss PolisherNTI GoldstarNTI Green AbrasiveNTI PDQ PolisherNTI PDQ2 PolisherNTI Pink AbrasiveNTI Silicone PolisherNTI White AbrasiveOcclubrush Assorted KitOcclubrush Cups & PointsOpti1Step PolishersOptiCleanOptiShineOrtho Adhesive Removal Logic SetPDQ Composite Polishing Brush Logic SetPDQ2 Composite Polishing Logic SetPerfect Pearl and Petite Pearl Prophy Contra Angles and BrushesPersonalized Logic SetPin SpannhalterPINIDENTOFLEX GOLD/PRECIOUS MEPINIDENTOFLEX Pin-Holder MAXIPolisher Century PackPORCELAIN / CERAMICS NG Polishers & PrepolishersPorcelain Adjusting & Polishing Logic SetPro-BrushPro-Cup Junior, Latch Type, StandardPro-Cup Junior, Screw-Type, StandardPro-Cup Latch Type SoftPro-Cup, Screw-Type, SoftProGloss Ultimate Composite Polishing Logic SetProphy BrushesRazor Sculpt and Polishing Logic SetShammy Bright DiscsSUPER ACRYLIC POLISHERsUltimate FG IntraOral Logic SetUltraGloss Composite Polishing Logic SetValplast Logic SetZir-Cut Polisher Logic SetZir-Cut Zirconia Polisher | 1996 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Seal-Tight | 2007 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Automix TipsBayonet RingsDispensing TipsDynamic Mixing TipsFree-Flo Syringe, TipsIntra-oral TipsMixing TipsRoot Canal TipsStatic Mix TipsWastesaver Tips | 1977 |
| Amalgam AlloyEJJ · Class 2 | — | Maker | ContourTytinTytin FC | 2007 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | — | 1989 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Barbed BroachHedstrom FilesK-FilesK-Flex FilesK3 FilesK3XF FilesLA AxxessLightSpeed CRXLightSpeed LSXPathfinder 14 morePathfinder CSQuantec Axxess FilesQuantec FilesRetreatment FilesRoot Canal ReamersTF (Twisted Files)TF Adaptive FilesTraverse FilesTraverse Glide Path FileTraverse Orifice and Glide Path FileTraverse Orifice OpenerTriple Flex FilesZenFlex FilesZenFlex One Sterile and Non-Sterile Files | 1996 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | elements Connectelements motorEndoTouch TC2M4 TC2 Handpiece | 2017 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | — | 2007 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | Ormco Digital Bonding | 2023 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | ACCO ExpanderAcrylic Bonded RPEActivatorsAdaptorArnold ExpanderBand and Loop Space MaintainerBionatorBluegrass Tongue TrainerCetlin Lip BumperDeLuke Bonded Framless Expander 44 moreDischinger Lower Expansion ApplianceDistal JetDistal Jet Molar UprighterEZ Bond RetainerFan Expider ExpanderFrankelGoshgarian Transpalatal ArchHaas ExpanderHawley RetainerHayrake -- Palatal with SpursHex Appliance (Hilgers)Hilgers PendexHilgers PendulumJackson ExpanderKiddie PartialLingual ArchLower Bi-HelixLower ExpanderMAH Freedom AppliancesMayes PenguinMCLRNance ButtonNord ExpanderOrthodontic Appliance and PartsOrthopedic CorrectorPalatal Thumb CribPhD AppliancePorter ArchProactive (Spring Retainer)Rachet ExpanderRapid Palatal ExpanderSagittal AppliancesSchwarz AppliancesShamey ExpanderSpring Jet ExpandersSpring Loaded Space RegainerSpring RetainerTracey/Hilgers MDA ApplianceTranspalatal ArchTwin BlockUpper or Lower Removable QuadVertical CribW Arch ExpanderWilson 3-D Appliance | 2005 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | MIxing Tips | 2014 |
| Amalgam Dental CapsuleDZS · Class 1 | — | Maker | Self-Activating Capsules for Contour, Tytin, and Tytin FCTytin | 1997 |
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Maker | Light Guides for Curing Lights | 1992 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | Dragonfly ErgoZoomDragonfly NEODragonfly PRODragonfly RDHSparkSpark TruColorZeon EndeavourZeon Endeavour MDZeon Endeavour TruColorZeon Endeavour TruColor XL 1 moreZeon Endeavour XL | 2002 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | SoftClamp | 2006 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Lister | elements 8:1 Dental Handpiece | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Bite WaferDisclosing WaxOcclusal Indicator Wax | 1977 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | M4 HandpiecePerfectPearl Disposable Prophy AnglePetitePearl Disposable Prophy Angle | 2019 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Digital Imaging & AccessoriesEndo-Bite SensoHawe Imaging Plate Holder TestHawe Testset X-RayKwik-BiteSuper-BiteSuper-Bite Senso | 1996 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | OptiViewOptiView Premier | 2005 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | — | 2004 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Life | 1984 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | CleanicCleanpolishClinproHawe Paste for ImplantsLuster PasteProphy PasteShammy Bright Polishing PasteSuperpolish | 2000 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | Ruddle Post Removal System | 2012 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Cure-Thru MatricesPolishersPre-contoured Metal BandsSuperCap Matrices, Steel, CervicalWedge Bags | 1995 |
| Root Canal Irrigation Air-Powered HandpieceNYL · Class 1 | — | Maker | EndoVac Apical Negative Pressure Irrigation System | 2014 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Gates Glidden Drills | 1999 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | Softline | 2008 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | ZenSeal Pro Syringe Barrel and Plunger | 2025 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | ALLRAP/SLIP-N-GRIP | 2009 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Lister | OPTIMIXVolume Machine | 2005 |
| Articulation PaperEFH · Class 1 | — | Maker | Flex TabsHigh Spot Indicating PasteHigh Spot Indicating Spray | 2007 |
| X-Ray Beam AlignerEHA · Class 1 | — | Lister | Dispose-a-Bite | 2007 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | Perforated Diamond Strips | 2010 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | ZenSeal Pro ZenSave Trimmable TipsZenSeal Tips | 2008 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Comporoller | 1985 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | — | 1992 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Lister | CeraGlaze SpiralDiaGloss SpiralNTI SoftMat WheelPolishing BrushesUnique Spiral | 2009 |
| Operative Margin Finishing FileEKA · Class 1 | Dental hand instruments | Maker | SmartStrip | 2016 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | Carr Explorer | 1989 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Finger Spreaders | 1996 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Lister | SmearClear Mix | 2019 |
| MercuryELY · Class 2 | — | Maker | Tytin | 2011 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Discovery Trays | 1977 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | AOB SplintBleaching TraysBruxism SplintDamon Retention SplintElast-AcrylFlat Plane SplintFlexiclearHerbst Appliance Acrylic SplintImpakImpak Positioner 6 moreIntrusion SplintMora/Gelb SplintPro-FlexRepositioning SplintSilicone Positioner (Pro-Flex)Starnes Orthotic Appliance | 2004 |
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 Sybron Dental Specialties as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Jan 2026 | K252890 | ZenSeal Pro | KIF Root Canal Filling Resin |
| 20 Feb 2025 | K250487 | SparkTM Clear Aligner System | NXC Sequential Aligner |
| 3 Jan 2025 | K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 11 Oct 2024 | K240501 | Spark Clear Aligner System | NXC Sequential Aligner |
| 12 Jan 2023 | K222830 | Rainbow 360 | KLE Resin Tooth Bonding Agent |
| 31 Aug 2022 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | EBF Resin Tooth Shade Material |
| 22 Mar 2021 | K203737 | Spark Clear Aligner System | NXC Sequential Aligner |
| 11 Oct 2019 | K191548 | Nexus Universal Self-Cure | EMA Dental Cement |
| 7 Nov 2018 | K182162 | OptiBond eXTRa Universal | KLE Resin Tooth Bonding Agent |
| 11 Oct 2018 | K182826 | Ormco Spark Aligner System | NXC Sequential Aligner |
| 31 Jan 2018 | K172845 | Symetri Clear | NJM Orthodontic Ceramic Bracket |
| 18 Jul 2017 | K171844 | Inspire ICE aka Inspire ICE Clear Brackets | NJM Orthodontic Ceramic Bracket |
| 18 Jul 2017 | K163064 | Demi Ultra | EBZ Ultraviolet Activator for Polymerization |
| 21 Dec 2016 | K162436 | EndoVac Pure | NYL Root Canal Irrigation Air-Powered Handpiece |
| 7 Nov 2016 | K162257 | P1145 Dental Restorative | EBF Resin Tooth Shade Material |
| 5 Aug 2016 | K160097 | Image Fast Set, Image Regular Set | ELW Impression Material |
| 27 Jul 2016 | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | KIF Root Canal Filling Resin |
| 30 Jun 2016 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials | ELW Impression Material |
| 6 May 2016 | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | KIF Root Canal Filling Resin |
| 14 Apr 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | KIF Root Canal Filling Resin |
| 10 Sep 2015 | K151526 | Zone, ZoneFree, Zone A1 | EMA Dental Cement |
| 17 Aug 2015 | K151332 | Nexus Universal, Nexus Universal Chroma | EMA Dental Cement |
| 19 Jun 2015 | K150559 | Life Fast Set, Life Regular Set | EJK Calcium Hydroxide Cavity Liner |
| 5 Feb 2015 | K143209 | SonicFill 2 | EBF Resin Tooth Shade Material |
| 5 Dec 2014 | K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | NOF Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression System |
| 30 May 2013 | K130869 | TAKE 1 ADVANCE | ELW Impression Material |
| 26 Mar 2013 | K123118 | INSIGNIA DIGICAST | DYW Orthodontic Plastic Bracket |
| 20 Mar 2013 | K123468 | DEMI ULTRA | EBZ Ultraviolet Activator for Polymerization |
| 13 Mar 2013 | K123416 | INSIGNIA WITH ITERO | DYW Orthodontic Plastic Bracket |
| 19 Feb 2013 | K123595 | NEXUS RMGI | EMA Dental Cement |
| 8 Feb 2013 | K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | NOF Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression System |
| 9 Aug 2012 | K121524 | INSIGNIA | DYW Orthodontic Plastic Bracket |
| 16 Nov 2011 | K112640 | HYPERELASTIC WIRE | DZC Orthodontic Wire |
| 14 Jun 2011 | K110747 | TEMPFLEX | EBG Resin Temporary Crown and Bridge |
| 8 Apr 2011 | K110092 | TAKE 1 ADVANCED RIGID TRAY | ELW Impression Material |
| 5 Apr 2011 | K110378 | IMPRESSION COMPOUND | ELW Impression Material |
| 28 Jan 2011 | K102621 | SOLSTICE | EBZ Ultraviolet Activator for Polymerization |
| 20 Jan 2011 | K103351 | DMC COMPOSITE 2 | EBF Resin Tooth Shade Material |
| 16 Oct 2010 | K102163 | REALSEAL XT SEALER | KIF Root Canal Filling Resin |
| 13 Sep 2010 | K101676 | CLEARARCH | DYW Orthodontic Plastic Bracket |
| 27 Aug 2010 | K093821 | FS ALIGNER | NXC Sequential Aligner |
| 30 Jul 2010 | K101423 | OPTIBOND XTR | KLE Resin Tooth Bonding Agent |
| 30 Apr 2010 | K100347 | OPTIBOND SE | KLE Resin Tooth Bonding Agent |
| 5 Apr 2010 | K093341 | CENTURY MODEL 105C | EFB Dental Air-Powered Handpiece |
| 19 Mar 2010 | K100083 | ESTHETICA | EBF Resin Tooth Shade Material |
| 28 Jan 2010 | K092176 | TAKE 1 ADVANCED RIGID TRAY | ELW Impression Material |
| 27 Jan 2010 | K093484 | PREMISE FLOWABLE MODIFIED | EBF Resin Tooth Shade Material |
| 14 Oct 2009 | K091091 | SONICFILL 2010 | EBF Resin Tooth Shade Material |
| 7 Oct 2009 | K091613 | TAKE 1 | ELW Impression Material |
| 21 May 2009 | K091023 | METAMORPHOSIS | EBF Resin Tooth Shade Material |
| 3 Apr 2009 | K090292 | PREMISE MODIFIED | EBF Resin Tooth Shade Material |
| 11 Dec 2008 | K082671 | HERCULITE ULTRA | EBF Resin Tooth Shade Material |
| 24 Oct 2008 | K081900 | TEMPORARY TOOTH REPLACEMENT | DZE Root-Form Endosseous Implant |
| 24 Sep 2008 | K081415 | DAMON 4CLEAR | NJM Orthodontic Ceramic Bracket |
| 4 Sep 2008 | K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | ELC Ultrasonic Scaler |
| 3 Sep 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | EFB Dental Air-Powered Handpiece |
| 12 Aug 2008 | K081695 | DMC COMPOSITE | EBF Resin Tooth Shade Material |
| 29 Jan 2008 | K073209 | MAXCEM 2 | MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain Relief |
| 4 Dec 2007 | K072622 | STANDOUT 2 | ELW Impression Material |
| 21 Sep 2007 | K071615 | FIXAFLOSS | EEF Rubber Dam Clamp |
| 10 Sep 2007 | K071429 | TI2200 TRANSILLUMINATION CABLE | NTK Light Transmission Caries Detector |
| 26 Jul 2007 | K071251 | DEMI | EBZ Ultraviolet Activator for Polymerization |
| 19 Jul 2007 | K071288 | MODIFICATION TO KAVO QUATTROCARE | EBF Resin Tooth Shade Material |
| 25 May 2007 | K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR | LRK Anti-Snoring Device |
| 19 Jan 2007 | K061042 | LINGLOCK | DYW Orthodontic Plastic Bracket |
| 13 Dec 2006 | K062856 | TF ROTARY NICKEL TITANIUM FILE | EKS Endodontic Pulp Canal File |
| 5 Dec 2006 | K063116 | DEMETRON A.2 | EBZ Ultraviolet Activator for Polymerization |
| 19 Oct 2006 | K062519 | NEXUS 3 | EMA Dental Cement |
| 3 Aug 2006 | K061230 | VECTORS TEMPORARY ANCHORAGE SYSTEM | OAT Orthodontic Endosseous Implant |
| 6 Jul 2006 | K061481 | GRENGLOO | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 28 Apr 2006 | K060472 | PREMISE FLOWABLE | EBF Resin Tooth Shade Material |
| 28 Mar 2006 | K060469 | OPTIBOND ALL-IN-ONE | KLE Resin Tooth Bonding Agent |
| 3 Feb 2006 | K053565 | TEMPBOND CLEAR WITH TRICLOSAN | EMA Dental Cement |
| 3 Jan 2006 | K051933 | EXPASYL POWER APPLICATOR | ELW Impression Material |
| 30 Nov 2005 | K052477 | DAMON 3 MODIFIED | DYW Orthodontic Plastic Bracket |
| 15 Apr 2005 | K050604 | KERR VPS IMPRESSION MATERIAL | ELW Impression Material |
| 15 Nov 2004 | K042422 | D3 CHROMA | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 10 Nov 2004 | K042888 | DEMETRON IDS CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 21 Jul 2004 | K041474 | MAXCEM | EMA Dental Cement |
| 18 Jun 2004 | K040874 | RED, WHITE & BLUE | NXC Sequential Aligner |
| 13 Nov 2003 | K032921 | PREMISE | EBF Resin Tooth Shade Material |
| 15 Oct 2003 | K032408 | DAMON FT | DYW Orthodontic Plastic Bracket |
| 6 Oct 2003 | K032407 | OPTIBAND LC | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 29 Sep 2003 | K032042 | ENVISION | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 3 Jul 2003 | K031484 | STAND OUT | ELW Impression Material |
| 2 Jul 2003 | K031476 | FILL-IN | EBG Resin Temporary Crown and Bridge |
| 27 Jun 2002 | K021797 | L.E.DEMETRON | EBZ Ultraviolet Activator for Polymerization |
| 1 May 2002 | K020502 | SOLO ORTHO 3 | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 29 Mar 2002 | K020267 | OPTILUX CURING LIGHTS | EBZ Ultraviolet Activator for Polymerization |
| 4 Feb 2002 | K014179 | DEMETRON LC | EBZ Ultraviolet Activator for Polymerization |
| 4 Feb 2002 | K013895 | TEMPFIL | EBG Resin Temporary Crown and Bridge |
| 18 Jan 2002 | K013510 | POINT 4 MODIFIED | EBF Resin Tooth Shade Material |
| 16 Jan 2002 | K013647 | REVOLUTION FORMULA 2 | EBF Resin Tooth Shade Material |
| 16 Jan 2002 | K013609 | NEXUS 2 CLEAR | EMA Dental Cement |
| 9 Jan 2002 | K013529 | POINT 4 TRANSLUCENT MODIFIED | EBF Resin Tooth Shade Material |
| 25 Oct 2001 | K012717 | LIFE 2 | EJK Calcium Hydroxide Cavity Liner |
| 3 Oct 2001 | K013009 | BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 | EBF Resin Tooth Shade Material |
| 2 Oct 2001 | K013008 | NEXUS 2 MODIFIED | EMA Dental Cement |
| 1 Oct 2001 | K013007 | BELLEGLASS HP ENAMEL 2 | EBF Resin Tooth Shade Material |
| 20 Sep 2001 | K012082 | OPTIBOND SOLO PLUS ACTIVATOR | KLE Resin Tooth Bonding Agent |
| 4 Sep 2001 | K012405 | EXTRUDE MODIFIED | ELW Impression Material |
| 30 Aug 2001 | K012322 | OPTIBOND 2 | KLE Resin Tooth Bonding Agent |
| 27 Aug 2001 | K012321 | POINT 4 FLOWABLE | EBF Resin Tooth Shade Material |
| 14 Aug 2001 | K011798 | CORERESTORE 2 | EBF Resin Tooth Shade Material |
| 20 Jun 2001 | K010940 | SEALAPEX 4 | KIF Root Canal Filling Resin |
| 23 Apr 2001 | K010994 | TAKE ONE BITE MODIFIED | ELW Impression Material |
| 1 Mar 2001 | K003808 | TAKE 1 | ELW Impression Material |
| 22 Feb 2001 | K003640 | MINIENDO III | ELB Rotary Scaler |
| 15 Feb 2001 | K003650 | PERMLASTIC 3 | ELW Impression Material |
| 4 Jan 2001 | K003658 | TEMP-BOND NE 2 | EMA Dental Cement |
| 28 Aug 2000 | K001899 | IMPROVED TRY-IN GEL | EBF Resin Tooth Shade Material |
| 22 Aug 2000 | K001881 | IMPROVED ENLIGHT LV | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 10 Aug 2000 | K001655 | PERMLASTIC 2 | ELW Impression Material |
| 21 Jul 2000 | K001876 | TAKE 1 BITE | ELW Impression Material |
| 17 May 2000 | K000530 | BELLEGLASS HP ENAMEL | EBF Resin Tooth Shade Material |
| 28 Apr 2000 | K000954 | KERR GEL ETCHANT | KLE Resin Tooth Bonding Agent |
| 24 Mar 2000 | K000436 | BELLEGLASS HP TRANSLUCENT DENTIN | EBF Resin Tooth Shade Material |
| 23 Mar 2000 | K000269 | BELLEGLASS HP OPACEOUS DENTIN | EBF Resin Tooth Shade Material |
| 17 Mar 2000 | K994309 | SOLO ORTHO 2 | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 8 Oct 1999 | K992195 | QUANTEC-E IRRIGATION SYSTEM 2 | EIA Operative Dental Unit |
| 18 Aug 1999 | K992160 | NEXUS 2 | EMA Dental Cement |
| 18 Aug 1999 | K992118 | PRODIGY 4 TRANSLUCENT SHADES | EBF Resin Tooth Shade Material |
| 9 Jul 1999 | K991808 | OPTIBOND SOLO PLUS 2 | KLE Resin Tooth Bonding Agent |
| 24 Jun 1999 | K991035 | QUANTEC-E IRRIGATION SYSTEM | EIA Operative Dental Unit |
| 4 Jun 1999 | K990743 | SOLO ORTHO | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 26 May 1999 | K990739 | QUANTEC-E ENDO SYSTEM | EKX Ac-Powered Direct Drive Handpiece |
| 6 Apr 1999 | K990898 | PRODIGY 4 | EBF Resin Tooth Shade Material |
| 8 Mar 1999 | K990498 | OPTIBOND SOLO PLUS | KLE Resin Tooth Bonding Agent |
| 25 Feb 1999 | K990252 | SOLO PLUS ORTHO | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Feb 1999 | K990225 | ENDO ANALYZER, MODEL 8005, MODIFIED | EAT Pulp Tester |
| 21 Jan 1999 | K984362 | ENLIGHT LV | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 20 Jan 1999 | K984217 | ENLIGHT-2 | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 18 Nov 1998 | K983370 | PRODIGY- 3 | EBF Resin Tooth Shade Material |
| 16 Oct 1998 | K982917 | B-SYSTEM SILICONE | ELW Impression Material |
| 8 Oct 1998 | K982590 | TEMPBOND CLEAR-2 | EMA Dental Cement |
| 30 Sep 1998 | K982459 | TEMPFIL F - 2 | EBG Resin Temporary Crown and Bridge |
| 31 Jul 1998 | K982148 | PRODIGY 2 | EBF Resin Tooth Shade Material |
| 16 Jun 1998 | K981448 | KERR HARD DENTURE RELINE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 9 Jan 1998 | K974105 | KERR COMPOMER | EBF Resin Tooth Shade Material |
| 8 Dec 1997 | K973439 | ENDO ANALYZER, MODEL 8005 | EAT Pulp Tester |
| 26 Sep 1997 | K972858 | KERR NEXUS ONE BOTTLE ADHESIVE | KLE Resin Tooth Bonding Agent |
| 16 Sep 1997 | K972890 | ENLIGHT (TENTATIVE NAME) | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 12 Sep 1997 | K971762 | BELLEGLASS HP ENAMEL REPAIR MATERIAL | EBF Resin Tooth Shade Material |
| 15 Aug 1997 | K972369 | SEALAPEX | KIF Root Canal Filling Resin |
| 16 Apr 1997 | K970495 | FOUNDATION INDIRECT COMPOSITE RESIN | EBF Resin Tooth Shade Material |
| 7 Apr 1997 | K970715 | SYSTEM B HEAT SOURCE | EAT Pulp Tester |
| 10 Feb 1997 | K964981 | TEMPFIL C&B | EBG Resin Temporary Crown and Bridge |
| 22 Jan 1997 | K964191 | CALCIUM HYDROXIDE MEDICAMENT | EJK Calcium Hydroxide Cavity Liner |
| 4 Dec 1996 | K963736 | SOFT DENTURE REBASING RESIN | EBI Rebasing Repairing Relining Denture Resin |
| 2 Dec 1996 | K963862 | TOUCH N' HEAT | EAT Pulp Tester |
| 27 Nov 1996 | K963805 | PRODIGY AC | EBF Resin Tooth Shade Material |
| 19 Nov 1996 | K963786 | TEMPFIL F | EBG Resin Temporary Crown and Bridge |
| 30 May 1996 | K961708 | LIFE AND LIFE FAST SET | EJK Calcium Hydroxide Cavity Liner |
| 8 May 1996 | K961284 | KOLOR + | EBF Resin Tooth Shade Material |
| 4 Jan 1996 | K955333 | SPIRIT MB | DYW Orthodontic Plastic Bracket |
| 4 Jan 1996 | K954827 | SEALITE FL | EBC Pit and Fissure Sealant and Conditioner |
| 2 Jan 1996 | K955331 | BELLEGLASHP | EBG Resin Temporary Crown and Bridge |
| 11 Dec 1995 | K955068 | OPTIBOND 2A PRECOAT | EMA Dental Cement |
| 1 Dec 1995 | K955242 | TITANIUM BIRD BEAK PLIER | JEX Orthodontic Plier |
| 2 Nov 1995 | K954762 | NEXUS | EMA Dental Cement |
| 30 Oct 1995 | K954708 | SILANE PRIMER | KLE Resin Tooth Bonding Agent |
| 30 Oct 1995 | K954689 | CONNECT | EBI Rebasing Repairing Relining Denture Resin |
| 19 Oct 1995 | K954643 | TRY-IN GEL | EMA Dental Cement |
| 28 Sep 1995 | K953604 | SHAPING HEDSTROM N.T. | EKS Endodontic Pulp Canal File |
| 19 Jul 1995 | K951239 | GLOWING SPIRITS | DYW Orthodontic Plastic Bracket |
| 23 May 1995 | K951776 | BAND SEATER | ECR Orthodontic Band Setter |
| 27 Jan 1995 | K946255 | THERMASET | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 29 Dec 1994 | K945539 | OPTIGUARD | EBF Resin Tooth Shade Material |
| 29 Dec 1994 | K945244 | PULP CANAL SEALER EWT | EMA Dental Cement |
| 8 Dec 1994 | K944659 | PRODIGY | EBF Resin Tooth Shade Material |
| 29 Nov 1994 | K944416 | LIFE | EJK Calcium Hydroxide Cavity Liner |
| 17 Nov 1994 | K943642 | HERCULITE XR & XRV | EBF Resin Tooth Shade Material |
| 3 Nov 1994 | K944480 | SEALAPEX | EMA Dental Cement |
| 9 Sep 1994 | K943738 | OPTIBOND-D | KLE Resin Tooth Bonding Agent |
| 23 Aug 1994 | K943245 | SPIRIT MB | DYW Orthodontic Plastic Bracket |
| 17 Aug 1994 | K943068 | MAGNEFORCE | ECO Orthodontic Spring |
| 10 Jun 1994 | K942393 | TUBLI-SEAL EWT | KIF Root Canal Filling Resin |
| 29 Apr 1994 | K940675 | SYBRALOY | EJJ Amalgam Alloy |
| 31 Mar 1994 | K941015 | ORMCO SYSTEM 1+ (TM) | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 31 Mar 1994 | K940845 | SYSTEM 1 | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 22 Mar 1994 | K940379 | EXTRUDE | ELW Impression Material |
| 20 Oct 1993 | K922806 | ORMCO SPORTSGUARD | EJF Orthodontic Metal Bracket |
| 5 May 1993 | K923405 | THE HERBST APPLIANCE | EJF Orthodontic Metal Bracket |
| 4 Dec 1992 | K923556 | ADP FACEMASK | DZB Orthodontic Extraoral Headgear |
| 27 Oct 1992 | K923399 | CHALLENGE II - PASTE ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 5 May 1992 | K921245 | THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 21 Apr 1992 | K921385 | IMPROVED SEQUENCE LIGHT CURE ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 17 Jan 1992 | K914727 | SEQUENCE LIGHT CURE ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 20 Nov 1991 | K914616 | KLEER(TM) ORTHODONTIC BRACKET | EJF Orthodontic Metal Bracket |
| 27 Dec 1990 | K905197 | THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM | EJT Gold-Based Noble Metal Alloy |
| 6 Sep 1990 | K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | DZB Orthodontic Extraoral Headgear |
| 6 Sep 1990 | K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL | DZB Orthodontic Extraoral Headgear |
| 2 Apr 1990 | K900184 | LINGUAL SHEATH | EJF Orthodontic Metal Bracket |
| 8 Mar 1990 | K896913 | SPIRIT | DYW Orthodontic Plastic Bracket |
| 15 Sep 1989 | K894781 | OPTIFLEX | EJF Orthodontic Metal Bracket |
| 15 Sep 1989 | K894358 | LUMINA ORTHODONTIC BRACKET | EJF Orthodontic Metal Bracket |
| 12 Jun 1989 | K892704 | GEM II ORTHODONTIC BRACKET | EJF Orthodontic Metal Bracket |
| 25 Apr 1989 | K890740 | FRS LITE FLUORIDE RELEASING SEALANT | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 19 Feb 1987 | K870536 | GEM ORTHODONTIC BRACKET | EJF Orthodontic Metal Bracket |
| 21 Jan 1987 | K863709 | CHALLENGE ORTHODONTIC BONDING ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 11 Jul 1986 | K862538 | SENTRY BREAKWAY NECK STRAP | DZB Orthodontic Extraoral Headgear |
| 29 Aug 1985 | K852894 | ORMCO TRANSMANDIBULAR IMPLANT | MDL Transmandibular Implant |
| 15 Mar 1978 | K780239 | BRACKET, METAL REINFORCED PLASTIC | DYW Orthodontic Plastic Bracket |
Some of these clearances are listed with FDA today by another company: KaVo Dental GmbH (4), A-dec, Inc. (2), Electro Medical Systems SA (1), GC America Inc. (1).
Also lists devices cleared under other names
Sybron Dental Specialties 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: Jeneric/Pentron, Inc. (11), Pentron Clinical Technologies (5), Kerr Dental Materials Center (5), Sybron Endo/Analytic (3), Kerr Corporation (Danbury) (3), Meta Systems Co., Ltd. (2), Pentron Corp. (2), Nsk Nakanishi, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Oct 2025 | K253461 | Demi Pro | Meta Systems Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 21 Sep 2022 | K210475 | EQ-M | Meta Systems Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 7 Jun 2019 | K190503 | CeraSeal | Meta Biomed Co, Ltd | KIF Root Canal Filling Resin |
| 17 Mar 2017 | K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | EFA Dental Belt and/or Gear Driven Handpiece |
| 21 Feb 2017 | K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | EBW Handpiece and Cord Foot Controller |
| 2 Jul 2014 | K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | Sybron Endo | NYL Root Canal Irrigation Air-Powered Handpiece |
| 20 Apr 2012 | K120037 | BLUWHITE DIAMOND DENTAL BURS MODIFIED | Beavers Dental, Div. Sybron Canada, Ltd. | DZP Dental Diamond Instrument |
| 14 Jun 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 30 Oct 2009 | K091512 | BUILD-IT LIGHT CURE | Pentron Clinical Technologies | EBF Resin Tooth Shade Material |
| 29 Aug 2008 | K081887 | LUTE-IT II VENEER CEMENT, MODEL NO6 | Pentron Clinical Technologies | EMA Dental Cement |
| 21 Nov 2007 | K072480 | GENERATION 8 SE ADHESIVE | Pentron Clinical Technologies | KLE Resin Tooth Bonding Agent |
| 26 Oct 2007 | K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 | Pentron Clinical Technologies | EBF Resin Tooth Shade Material |
| 10 May 2006 | K060698 | CEMENT-IT ALL PURPOSE, MODEL N97 | Pentron Clinical Technologies | EMA Dental Cement |
| 28 Apr 2004 | K031664 | ELEMENTS OBTURATION UNIT | Sybron Endo/Analytic | EKR Endodontic Root Canal Plugger |
| 2 Jul 2003 | K031444 | OPTIBOND FL | Kerr Dental Materials Center | KLE Resin Tooth Bonding Agent |
| 14 Apr 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 1 Aug 2002 | K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL | Pentron Corp. | EBG Resin Temporary Crown and Bridge |
| 5 Jul 2002 | K021253 | ULTRASONIC TIPS WITH DIAMOND COATING | Sybron Endo/Analytic | ELC Ultrasonic Scaler |
| 19 Jun 2002 | K021298 | ELEMENTS DIAGNOSTIC UNIT | Sybron Endo/Analytic | EAT Pulp Tester |
| 22 Apr 2002 | K020555 | SONATA MICRO HYBRID COMPOSITE | Pentron Laboratory Technologies | EBF Resin Tooth Shade Material |
| 22 Feb 2002 | K020092 | TEMPHASE | Kerr Dental Materials Center | EBG Resin Temporary Crown and Bridge |
| 14 Feb 2002 | K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) | Jeneric/Pentron, Inc. | KLE Resin Tooth Bonding Agent |
| 29 Oct 2001 | K013375 | BELLEGLASS HP OPAQUE 2 | Kerr Dental Materials Center | EBF Resin Tooth Shade Material |
| 5 Jul 2000 | K001218 | CORRECT PLUS | Jeneric/Pentron, Inc. | ELW Impression Material |
| 28 Apr 2000 | K000357 | EZ CONNECT RESIN | Kerr Dental Materials Center | EBF Resin Tooth Shade Material |
| 14 Apr 2000 | K000346 | EZ CONNECT | Kerr Dental Materials Center | EBG Resin Temporary Crown and Bridge |
| 17 Mar 2000 | K000211 | BUILD-IT FR | Jeneric/Pentron, Inc. | EBF Resin Tooth Shade Material |
| 29 Feb 2000 | K000173 | CEMENT IT! UNIVERSAL C&B | Jeneric/Pentron, Inc. | EMA Dental Cement |
| 24 Mar 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Nsk Nakanishi, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 18 Feb 1999 | K984483 | A-SOFT RELINER | S & C Polymer GmbH | EBI Rebasing Repairing Relining Denture Resin |
| 9 Nov 1998 | K983266 | FIBREKOR POST SYSTEM | Jeneric/Pentron, Inc. | ELR Root Canal Post |
| 11 Mar 1998 | K980195 | FACEBOW | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 17 Dec 1997 | K974131 | ALERT | Jeneric/Pentron, Inc. | EBF Resin Tooth Shade Material |
| 12 Sep 1997 | K973388 | DENTIN CONDITIONING AND ADHESIVE (BOND 1) | Jeneric/Pentron, Inc. | KLE Resin Tooth Bonding Agent |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 11 Mar 1996 | K955932 | EXAFLEX IMPRESSION MATERIAL (MODIFICATION) | GC America Inc. | ELW Impression Material |
| 21 Feb 1996 | K960352 | ALLRAP/SLIP-N-GRIP | Dental Disposables Intl., Inc. | EFB Dental Air-Powered Handpiece |
| 7 Sep 1995 | K953859 | BOND-IT DUAL CURE ACTIVATOR | Jeneric/Pentron, Inc. | KLE Resin Tooth Bonding Agent |
| 28 Aug 1995 | K952662 | COMP=FLOW | Jeneric/Pentron, Inc. | EBF Resin Tooth Shade Material |
| 6 Jun 1995 | K951663 | TYTIN R | Kerr Corporation (Danbury) | EJJ Amalgam Alloy |
| 23 May 1995 | K951238 | SAFE-TIPS EZ | Safe Wave Products, Inc. | EIA Operative Dental Unit |
| 15 Mar 1994 | K936222 | DENTIN CONDITIONING AND ADHESIVE SYSTEM | Jeneric/Pentron, Inc. | KLE Resin Tooth Bonding Agent |
| 11 Mar 1994 | K935535 | TYTIN | Kerr Corporation (Danbury) | EJJ Amalgam Alloy |
| 14 Feb 1994 | K934714 | ENDODONTIC PULP CANAL SPREADER | Excellence IN Endodontics, Inc. | ELC Ultrasonic Scaler |
| 28 Apr 1992 | K914178 | CORRECTED-V.P.S. | Jeneric/Pentron, Inc. | ELW Impression Material |
| 16 Apr 1990 | K895386 | GLASION | Scientific Pharmaceuticals | EMA Dental Cement |
| 11 Feb 1988 | K874189 | DUAL-CURE RADIOPAQUE | Pentron Corp. | EBF Resin Tooth Shade Material |
| 18 May 1987 | K871591 | ORMCO GEL-ETCH | Scientific Pharmaceuticals | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Oct 1984 | K843023 | KERR PORCELAIN REPAIR PRIMER | Kerr Corporation (Danbury) | KLE Resin Tooth Bonding Agent |
| 24 Feb 1982 | K820181 | SYBRON/KERR CONTOUR | Sybron Corp. | EJJ Amalgam Alloy |
| 14 Apr 1981 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | Dental-Material Gesellschaft | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Allesee Orthodontic Appliances, Inc.FDA reg. 2184045 | Sturtevant, WI, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| EH Dental Services Costa Rica Sociedad de Responsabilidad LimitadaFDA reg. 3027500898 | Escazu, San Rafael San Jose, Costa Rica | Contract manufacturer |
| EH Labs CZ s.r.o.FDA reg. 3028340833 | Dvur Kralove nad Labem Hradec Kralove, Czechia | Contract manufacturer |
| Envista (Sichuan) Medical Device Co., Ltd.FDA reg. 3031606517 | Ziyang Sichuan, China | Contract manufacturer |
| Envista (Suzhou) Medical Device Co., Ltd.FDA reg. 3014749460 | Suzhou Jiangsu, China | Contract manufacturer |
| Envista (Suzhou) Medical Device Co., Ltd.FDA reg. 3045923493 | Suzhou Jiangsu, China | Contract manufacturer |
| Kerr CorporationFDA reg. 2024312 | ORANGE, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer |
| Kerr CorporationFDA reg. 3012477813 | Pomona, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Reprocessor, Specification developer |
| Kerr CorporationFDA reg. 3032378317 | Pomona, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer |
| Kerr Italia, S.r.l.FDA reg. 8020994 | SCAFATI Salerno, Italy | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| METREX RESEARCHFDA reg. 1722021 | Romulus, MI, United States | Complaint file establishment, Manufacturer |
| Metrex Research LLCFDA reg. 3003848022 | Madison, WI, United States | Manufacturer |
| Ormco CorporationFDA reg. 3013508670 | Pomona, CA, United States | Complaint file establishment, Manufacturer, Specification developer |
| Ormco CorporationFDA reg. 3015272949 | Brea, CA, United States | Complaint file establishment, Manufacturer, Specification developer |
| Ormex S. de R.L. de C.V.FDA reg. 8030637 | YUCATAN UMAN, Mexico | Contract manufacturer, Manufacturer |
| SDS de Mexico S. de R.L. de C.V.FDA reg. 9680845 | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer |
| SpofaDental a.s.FDA reg. 3007743883 | Jicin, Czechia | Contract manufacturer, Manufacturer |
Other names on FDA records
Allesee Orthodontic Appliances, Inc. · Kerr Corporation · Ormco Corporation · SpofaDental a.s. · Kerr Italia S.r.l. · Metrex Research LLC · SDS de Mexico, S. de R.L. de C.V. · Ormex S. de R.L. de C.V. · Envista (Suzhou) Medical Device Co., Ltd. · Envista (Sichuan) Medical Device Co., Ltd. · EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada · EH Labs CZ s.r.o.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9029565). 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.