Manufacturer registered with FDA
Nobel Biocare Services AG
Kloten, Switzerland. Lists 26 dental device types with FDA across 7 registered establishments, and holds 94 510(k) clearances as applicant.
- Device types listed
- 26
- Brands and models
- 478
- 510(k) clearances
- 942002–2026
- Markets registered in
- 162,749 registrations outside the US
- Establishments
- 7Belgium, Switzerland, Netherlands +2
510(k) clearances per year, 2000–2026
Registered in 16 markets
Where regulators' registries name Nobel Biocare Services AG as the manufacturer or the registration holder of a device.
RegisteredHome: SwitzerlandOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Nobel Biocare Services AG | 94 clearances | 2002–2026 | Below |
| Canada | Health Canada | Registration holder | NOBEL BIOCARE ABNOBEL BIOCARE USA LLC | 1,422 | 1999–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Nobel Biocare ABNobel Biocare Services AB | 417 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | NOBEL BIOCARE ABNOBEL BIOCARE USA, INC · NOBEL BIOCARE USA, LLC · +2 | 187 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NOBEL BIOCARE ABNOBEL BIOCARE AB PRODUKTION · NOBEL BIOCARE USA LLC · +2 | 115 | 1999–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Nobel Biocare AB | 114 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Nobel Biocare ABNobel Biocare · Nobel Biocare AB, Produktion · +2 | 87 | 1998–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Nobel Biocare AB | 75 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NOBEL BIOCARE ABNOBEL BIOCARE USA LLC · NOBEL BIOCARE USA, LLC | 70 | 2016–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Nobel Biocare AB | 67 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Nobel Biocare AB | 60 | 2003–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Nobel Biocare ABNobel Biocare Services AG | 52 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Nobel Biocare ABNobel Biocare USA, LLC · NOBEL BIOCARE LLC | 44 | — | Pure Global AI |
| China | NMPA | Registration holder | 诺贝尔生物公司Nobel Biocare AB诺贝尔生物公司 Nobel Biocare AB | 25 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Nobel Biocare AB | 13 | 2006–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NOBEL BIOCARE AB | 1 | 2025–2025 | 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 Nobel Biocare Services AG 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 | Abutment BlankAbutment Screw NobelReplaceAngulated Screw Channel (ASC) AbutmentAttachment SystemClinical Adapter for Zirconia AbutmentsClinical Screw CCClinical Screw Multi-unit Abutment N1 Trioval Conical ConnectionClinical Screw N1 BaseClinical Screw N1 Trioval Conical ConnectionClinical Screw Omnigrip 96 moreClinical Screw Omnigrip (Mini)Clinical Screw Omnigrip for Titanium RestorationClinical Screws for Astra Tech/ Straumann Bone Level/ Biomet/ Camlog/ ThommenConical Connection Cover ScrewsCoping ScrewCoronal ScrewDTX Studio DesignDTX Studio LabElos Accurate Customized AbtumentElos Accurate Hybrid Base and Customized Abutment with Prosthetic ScrewElos Accurate® Hexalobular Prosthetic ScrewElos Prosthetic ScrewElos Universal BaseEsthetic Abutment Conical ConnectionEsthetic Abutment N1 BaseEsthetic Abutment N1 TCCEsthetic Abutment NobelReplaceFull Contour Zirconia (FCZ) Implant CrownGold Coping Multi-unitGoldAdapt Branemark SystemGoldAdapt Conical ConnectionGoldAdapt NobelReplaceGuided Pilot Drill N1Healing Abutment Bmk Syst ZygomaHealing Abutment Conical ConnectionHealing Abutment N1 BaseHealing Abutment N1 Trioval Conical ConnectionHealing Abutments Bmk SystHealing Abutments PEEK Conical ConnectionHealing Cap Multi-unit TitaniumLegacy - Abutment NobelPerfectLegacy - Direct AbutmentLocatorMetal Adapter for Implant Bridge ClinicalMulti-Unit Abutment Branemark SystemMulti-Unit Abutment Plus Conical ConnectionMulti-Unit Abutment Trioval Conical ConnectionMulti-Unit Abutment Xeal Conical ConnectionMulti-Unit Abutment ZygomaMulti-unit Abutments Xeal ZygomaN1 Base IOS Healing AbutmentN1 Base Trioval Conical ConnectionNobel Biocare N1 Cover ScrewsNobel Biocare N1 TiUltra ImplantsNobelActive ImplantsNobelActive TiUltra ImplantsNobelDesignNobelDesign SoftwareNobelParallel CC TiUltra ImplantsNobelPearlNobelPearl Dental Implant SystemNobelProcera Abutments Branemark System TitaniumNobelProcera Abutments Conical Connection TitaniumNobelProcera Abutments Tri-Channel TitaniumNobelProcera Esthetic Implant Bridge ZirconiaNobelProcera Implant Bar OverdentureNobelProcera Implant Bridge ZirconiaNobelProcera Zirconia Abutments N1 BaseNobelProcera Zirconia Implant Crown N1 BaseNobelReplace CC TiUltra ImplantsNobelZygoma 0 ImplantsNobelZygoma Multi-unit Abutments Xeal Zygoma ScrewsNobelZygoma TiUltra ImplantsOmnigrip Prosthetic ScrewOn1 Base XealOn1 Clinical/ Prosthetic ScrewOn1 ConceptOn1 Healing CapOn1 IOS Healing CapsOn1 Universal AbutmentOsseoShaper 1OsseoShaper 2Procera Abutments Branemark System ZirconiaProcera Abutments NobelReplace ZirconiaProcera Implant Bridge TitaniumProcera Implant Bridge ZirconiaProsthetic Screw N1 BaseScrew Multi-Unit Branemark System/ NobelReplace/CCSnappy AbutmentTemporary Abutment Conical ConnectionTemporary Abutment N1 BaseTemporary Abutment N1 Trioval Conical ConnectionTemporary Abutments PEEK Conical ConnectionTemporary Coping Multi-unitTemporary Prosthetic ScrewTemporary Snap AbutmentTerrats MedicalTitanium Abutment Blank N1 TCCTrefoil Clinical ScrewTREFOIL FrameworkUniversal Abutment N1 BaseUniversal Abutment Trioval Conical ConnectionUniversal Base Abutment Conical ConnectionUniversal Base Conical ConnectionZygoma Implant Cover ScrewsZygoma Screw | 2007 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment ScrewAbutment Screw Branemark SystemBranemark System Cover ScrewsBranemark System Mk III TiU ImplantsClinical Screw CCClinical Screw Multi-unit Abutment N1 Trioval Conical ConnectionClinical Screw N1 BaseClinical Screw N1 Trioval Conical ConnectionConical Connection Cover ScrewsConverter Screw 65 moreEsthetic Abutment Branemark SystemEsthetic Abutment Conical ConnectionEsthetic Abutment NobelReplaceGold Coping Multi-unitGoldAdapt Conical ConnectionGuided Pilot Drill N1Healing Abutment Conical ConnectionHealing Abutment N1 Trioval Conical ConnectionHealing Abutment NobRplHealing Abutments PEEK Conical ConnectionHealing Cap Multi-unitHealing Screw ReplaceSelectLegacy Healing AbutmentsLocator Bar FemaleMulti-Unit Abutment Branemark SystemMulti-Unit Abutment NobelReplaceMulti-Unit Abutment Trioval Conical ConnectionMulti-Unit Abutment Xeal Conical ConnectionMulti-unit Abutments Xeal ZygomaN1 Base IOS Healing AbutmentN1 Base Trioval Conical ConnectionNobel Biocare N1 Cover ScrewsNobel Biocare N1 TiUltra ImplantsNobel Biocare S Series ImplantsNobelActive ImplantsNobelActive TiUltra ImplantsNobelParallel CC ImplantsNobelParallel CC TiUltra ImplantsNobelPearlNobelPearl Dental Implant SystemNobelProcera Abutments Conical Connection TitaniumNobelReplace CC TiUltra ImplantsNobelReplace Conical Connection ImplantsNobelReplace Conical Connection PMC ImplantsNobelReplace Cover ScrewsNobelSpeedy ImplantsNobelZygoma 0 ImplantsNobelZygoma 45 ImplantsNobelZygoma Multi-unit Abutments Xeal Zygoma ScrewsNobelZygoma TiUltra ImplantsNovum ScrewOn1 Base XealOsseoShaper 1OsseoShaper 2Prosthetic ScrewReplace Select TaperedReplace Select Tapered PMC ImplantsReplace Select TC ImplantsScrew Ceramic Branemark System/ NobelReplaceScrew Multi-Unit Branemark System/ NobelReplace/CCSnappy AbutmentSnappy Abutment NobelReplaceSnappy Abutments Branemark SystemTemporary Abutment Branemark SystemTemporary Abutment Conical ConnectionTemporary Abutment N1 BaseTemporary Abutment N1 Trioval Conical ConnectionTemporary Abutment NobelReplaceTemporary Abutments PEEK Conical ConnectionTrefoil Clinical ScrewTREFOIL FrameworkUniversal Abutment N1 BaseUniversal Abutment Trioval Conical ConnectionZygoma Implant Cover ScrewsZygoma Implants | 2007 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | AbutmentCADClinical Screw Multi-unit Abutment N1 Trioval Conical ConnectionClinical Screw N1 BaseClinical Screw N1 Trioval Conical ConnectionClinical Screw OmnigripDTX Studio designDTX Studio labElos Accurate Customized AbtumentElos Accurate Hybrid Base and Customized Abutment with Prosthetic ScrewElos Universal Base 26 moreGuided Pilot Drill N1Healing Abutment Conical ConnectionHealing Abutment N1 Trioval Conical ConnectionMulti-Unit Abutment Trioval Conical ConnectionMulti-Unit Abutment Xeal Conical ConnectionN1 Base IOS Healing AbutmentN1 Base Trioval Conical ConnectionNobel Biocare N1 Cover ScrewsNobel Biocare N1 TiUltra ImplantsNobelActive TiUltra ImplantsNobelParallel CC TiUltra ImplantsNobelReplace CC TiUltra ImplantsOmnigrip Prosthetic ScrewOn1 Base XealOn1 IOS Healing CapsOn1 Universal AbutmentOsseoShaper 1OsseoShaper 2Temporary Abutment Conical ConnectionTemporary Abutment N1 BaseTemporary Abutment N1 Trioval Conical ConnectionTitanium Abutment Blank N1 TCCUniversal Abutment N1 BaseUniversal Abutment Trioval Conical ConnectionUniversal Base Abutment Conical ConnectionUniversal Base Conical Connection | 2019 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Maker | NobelProcera Zirconia BridgeNobelProcera Zirconia Crown | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Release PinAbutment Replica Multi-unitAbutment Replica SnappyAbutment Retrieval Tools/Instruments TitaniumAbutment Retrieval Tools/Instruments ZirconiaAbutment Screw RemoverAbutment Screw Retrieval InstrumentAbutment Screw Retrieval Reverse DrillAdapter for Manual Torque Wrench ProstheticAdapter for Manual Torque Wrench Surgical 188 moreAdapter for RatchetAll-on-4 GuideApical Drill Temporary Snap Abutment / CopingBone Mill for N1 Trioval Conical ConnectionBone Mill Guide for Branemark SystemBone Mill Guide for Conical ConnectionBone Mill Guide for N1Bone Mill with Guide for Branemark SystemBone Mill with Guide for Conical ConnectionBone Mill with Guide for NobelZygomaBone Mill with Guide NobelReplaceBranemark System Open Tray Impression CopingBranemark System Zygoma Surgical KitBranemark System Zygoma Twist DrillsBranemark Zygoma Impression CopingCombined Open-end WrenchConical Connection Closed Tray Impression CopingConical Connection Open Tray Impression CopingConnection to HandpieceCounterbores Branemark SystemDensah BursDense Bone Drill TaperedDense Bone Drill Tapered Single-Patient UseDentalpointDepth IndicatorDepth ProbeDESS Dental Smart SolutionsDirection IndicatorDrill Extension ShaftDrill GuardDrill Guide Multi-unit Abutment PlusDrill KitDrill StopDrills TaperedDrills Tapered Single-Patient UseDuplicate DentureElos AccurateGuide drillsGuide Pin Implant LevelGuided Anchor PinGuided Anchor Pin SleevesGuided CounterboresGuided Cylinder with Pin for BranemarkGuided Cylinder with Pin for Conical ConnectionGuided Cylinder with Pin for NobelReplaceGuided Dense Bone DrillsGuided Dense Bone Screw TapsGuided Drill GuideGuided Implant Mounts Branemark SystemGuided Implant Mounts Conical ConnectionGuided Implant Mounts NobelActiveGuided Implant Mounts NobelParallelGuided Implant Mounts NobelReplaceGuided Implant Mounts NobelReplace Conical ConnectionGuided Pilot Drill N1Guided Pilot Drill SleevesGuided Pilot DrillsGuided Screw TapsGuided Screw Taps NobelParallelGuided SleeveGuided start drillGuided Start Drill/CounterboresGuided Tapered DrillsGuided Template AbutmentsGuided Tissue PunchesGuided Twist DrillsGuided Twist Step DrillsHandle for Guided Drill GuideHandle for Machine InstrumentsHandle for Protection AnalogsImplant AnalogImplant Driver Branemark SystemImplant Driver Conical ConnectionImplant Driver NobelReplaceImplant Driver Trioval Conical ConnectionImplant Replica Branemark SystemImplant Replica Conical ConnectionImplant Replica NobelPerfectImplant Replica NobelReplaceImplant Replica NovumImplant Replica NP IOS ModelImplant Replica TrefoilImplant Rescue CollarImplant Retrieval InstrumentIntra-oral Position LocatorIrrigation NeedleLab Screw Implant Level Branemark System/ NobelReplace/ CCLab Screw Multi-Unit Branemark System/ NobelReplaceLaboratory Guide Pin Implant LevelLaboratory Guide Pin Multi-unitLaboratory Guided PinLocatorMachine Ball ScrewdriverMachine Hex ScrewdriverMachine Multi-unit ScrewdriverMachine N1 Base ScrewdriverMachine Omnigrip Mini ScrewdriverMachine Omnigrip ScrewdriverMachine On1 ScrewdriverMachine Slot ScrewdriverMachine UniGrip ScrewdriverManual Ball ScrewdriverManual Hexagon ScrewdriverManual Implant DriverManual Multi-unit ScrewdriverManual N1 Base ScrewdriverManual Omnigrip Mini ScrewdriverManual Omnigrip ScrewdriverManual On1 ScrewdriverManual Slot ScrewdriverManual Torque Wrenche ProstheticManual Torque Wrenche SurgicalManual UniGrip ScrewdriverMetal Adapter Implant BridgeMounting ToolMulti-unit Abutment Plus ReplicaMulti-unit Aligning InstrumentMulti-unit Open/ Closed Tray Impression CopingMulti-unit plus Impression CopingN1 Base Open/Closed Tray Impression CopingN1 Base ReplicaN1 Implant ReplicaN1 IOS Replica Insertion ToolN1 Lab ScrewsN1 Position LocatorN1 ReplicaNobelParallel Conical Connection Cortical DrillsNobelPearlNobelPearl Dental Implant System, NobelPearlNobelPerfect Impression CopingNobelProcera IOS Replica Insertion ToolNobelReplace Open Tray Impression CopingNobelZygoma Twist DrillsNovum Impression CopingO-Ring Abutment AnalogOmnigrip Lab Screw CC / Tri-ChannelOmnigrip Mini Lab ScrewOn1 Closed/ Open Tray Impression CopingOn1 Prosthetic Lab ScrewOn1 Replica | 2003 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Trefoil Clinical ScrewTREFOIL Framework | 2017 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | Cannula internal coolingController, Foot, Handpiece And CordDEMO OsseoSet 200 (WS-75) SI-923, 230VDEMO OsseoSet 200 SI-923, 230VDental handpieceFoot ControlOsseoSet 200 (WS-75) SI-923, 230VOsseoSet 200 motor with cableOsseoSet 200 SI-915, 115VOsseoSet 200 SI-923, 230V | 2012 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Spare Parts: Overdenture Bar Attachments | 2009 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Carestream ScannerDTX Studio DesignDTX Studio LabKaVo LS3 ScannerMedit scanner and tipsNobelDesign | 2007 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | Clinical Screw Multi-unit Abutment N1 Trioval Conical ConnectionClinical Screw N1 BaseClinical Screw N1 Trioval Conical ConnectionGuided Pilot Drill N1Healing Abutment N1 Trioval Conical ConnectionMulti-Unit Abutment Trioval Conical ConnectionN1 Base IOS Healing AbutmentN1 Base Trioval Conical ConnectionNobel Biocare N1 Cover ScrewsNobel Biocare N1 TiUltra Implants 6 moreOsseoShaper 1OsseoShaper 2Temporary Abutment N1 BaseTemporary Abutment N1 Trioval Conical ConnectionUniversal Abutment N1 BaseUniversal Abutment Trioval Conical Connection | 2022 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Handpiece S-11, straight 1:1 | 2012 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Brasseler shank extensionDensah BursHager & Meissinger GmbHShort Densah BursZygoma Densah BursZygoma Tapered Drill | 2002 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | creos | 2021 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | creos | 2021 |
| Dental Stereotaxic InstrumentPLV · Class 2 | — | Lister | X-guide | 2021 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Lister | X-guide | 2021 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | CA | 2021 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | ASSAmed GmbH - MedizinbedarfASSAmed Y-ConnectorIrrigation Tube ElcomedIrrigation Tubing SetTube and Hose Sets | 2021 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | KaVo NOMAD | 2021 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | HANDLE INSTRUMENT | 1994 |
| Preformed AnchorEJX · Class 1 | — | Lister | CM LOC | 2021 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | BeaconSmart Pegs Type 1-115 | 2025 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | Punch | 2021 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | Surgical Handpiece | 2021 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | DEXIS Titanium, KaVo IXS HD | 2021 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Lister | creos | 2022 |
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 Nobel Biocare Services AG as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Aug 2026 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | NHA Endosseous Dental Implant Abutment |
| 18 Feb 2026 | K252197 | Nobel Biocare S Series Implants | DZE Root-Form Endosseous Implant |
| 25 Aug 2025 | K243834 | NobelZygoma TiUltra Implant system | DZE Root-Form Endosseous Implant |
| 3 Jan 2025 | K240346 | NobelProcera Zirconia Implant Bridge | NHA Endosseous Dental Implant Abutment |
| 24 Jan 2024 | K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | NHA Endosseous Dental Implant Abutment |
| 28 Apr 2023 | K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | NHA Endosseous Dental Implant Abutment |
| 16 Sep 2022 | K220339 | Esthetic Abutments Nobel Biocare N1 | NHA Endosseous Dental Implant Abutment |
| 29 Jul 2022 | K220048 | NobelProcera Zirconia N1 Base | NHA Endosseous Dental Implant Abutment |
| 21 Dec 2021 | K211109 | N1 TiUltra TCC Implant System | DZE Root-Form Endosseous Implant |
| 24 Sep 2021 | K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | DZE Root-Form Endosseous Implant |
| 3 Dec 2020 | K202452 | NobelProcera Zirconia Implant Bridge | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2020 | K202344 | TiUltra Implants and Xeal Abutments | DZE Root-Form Endosseous Implant |
| 30 Mar 2020 | K200040 | Universal Base Conical Connection (CC) | NHA Endosseous Dental Implant Abutment |
| 1 Mar 2019 | K181932 | DTX Studio design | PNP Dental Abutment Design Software for Dental Laboratory |
| 21 Feb 2019 | K173418 | NobelParallel Conical Connection | DZE Root-Form Endosseous Implant |
| 12 Dec 2018 | K181869 | On1 Universal Abutment | NHA Endosseous Dental Implant Abutment |
| 4 Dec 2018 | K183069 | NobelZygoma 0° | DZE Root-Form Endosseous Implant |
| 31 Oct 2018 | K180899 | Universal Base Abutment | NHA Endosseous Dental Implant Abutment |
| 14 Dec 2017 | K172854 | NobelPerfect Abutments | NHA Endosseous Dental Implant Abutment |
| 29 Nov 2017 | K171466 | NobelDesign, DTX Studio Design | NHA Endosseous Dental Implant Abutment |
| 26 Oct 2017 | K171142 | Healing Cap Multi-Unit Titanium | NHA Endosseous Dental Implant Abutment |
| 20 Oct 2017 | K172352 | TREFOIL System | DZE Root-Form Endosseous Implant |
| 11 May 2017 | K170135 | TREFOIL System | DZE Root-Form Endosseous Implant |
| 16 Mar 2017 | K161416 | Multi-unit Abutment Plus | NHA Endosseous Dental Implant Abutment |
| 14 Mar 2017 | K161598 | NobelZygoma 0° | DZE Root-Form Endosseous Implant |
| 28 Feb 2017 | K161655 | On1 Concept | NHA Endosseous Dental Implant Abutment |
| 22 Nov 2016 | K162043 | NobelProcera HT ML FCZ Bridge | ELL Porcelain Teeth |
| 22 Nov 2016 | K161435 | Temporary Snap Abutment | NHA Endosseous Dental Implant Abutment |
| 25 Jul 2016 | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | NHA Endosseous Dental Implant Abutment |
| 6 Jun 2016 | K153534 | NobelProcera HT ML Full Contour Zirconia Crown | ELL Porcelain Teeth |
| 2 Jun 2016 | K160119 | NobelSpeedy Groovy | DZE Root-Form Endosseous Implant |
| 2 Jun 2016 | K153036 | NobelDesign Software | NHA Endosseous Dental Implant Abutment |
| 11 Apr 2016 | K152836 | TREFOIL System | DZE Root-Form Endosseous Implant |
| 16 Mar 2016 | K152093 | NobelZygoma 45° | DZE Root-Form Endosseous Implant |
| 11 May 2015 | K142260 | NobelActive | DZE Root-Form Endosseous Implant |
| 24 Jul 2014 | K132749 | NOBELPROCERA OVERDENTURE BAR | NHA Endosseous Dental Implant Abutment |
| 8 May 2014 | K133731 | NOBELACTIVE WIDE PLATFORM (WP) | DZE Root-Form Endosseous Implant |
| 4 Apr 2014 | K133377 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE | NHA Endosseous Dental Implant Abutment |
| 30 Jan 2014 | K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION | NHA Endosseous Dental Implant Abutment |
| 5 Jun 2013 | K120954 | NOBELPROCERA PEEK ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 13 Mar 2013 | K122602 | NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS | NHA Endosseous Dental Implant Abutment |
| 28 Oct 2011 | K112259 | NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 23 Jun 2011 | K111581 | 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE | NHA Endosseous Dental Implant Abutment |
| 15 Jun 2011 | K110171 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS | NHA Endosseous Dental Implant Abutment |
| 9 Dec 2010 | K102436 | NOBEL ACTIVE 3.0 | DZE Root-Form Endosseous Implant |
| 31 Aug 2010 | K101714 | NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS | NHA Endosseous Dental Implant Abutment |
| 20 Aug 2010 | K100512 | NOBELPROCERA IPS E.MAX CROWN | EIH Porcelain Powder |
| 24 Jun 2010 | K093643 | MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS | NHA Endosseous Dental Implant Abutment |
| 16 Oct 2009 | K091848 | NOBEL/PROCERA IMPLANT BRIDGE | NHA Endosseous Dental Implant Abutment |
| 6 Oct 2009 | K091907 | NOBELPROCERA IMPLANT BRIDGE ZIRCONIA | NHA Endosseous Dental Implant Abutment |
| 25 Sep 2009 | K091904 | NOBELPROCERA ZI ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 22 Sep 2009 | K091756 | NOBELPROCERA TI ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 7 May 2009 | K090069 | PROCERA IMPLANT BRIDGE OVERDENTURE | NHA Endosseous Dental Implant Abutment |
| 13 Feb 2009 | K083205 | NOBELACTIVE 8.5 MM & 18.0 MM | DZE Root-Form Endosseous Implant |
| 19 Nov 2008 | K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | NHA Endosseous Dental Implant Abutment |
| 7 Nov 2008 | K081128 | MOLAR IMPLANT | DZE Root-Form Endosseous Implant |
| 22 Feb 2008 | K072129 | NOBELACTIVE ZIRCONIA ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 11 Jan 2008 | K073142 | NOBELREPLACE HEXAGONAL IMPLANT | DZE Root-Form Endosseous Implant |
| 28 Dec 2007 | K072570 | NOBELACTIVE MULTI UNIT ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 28 Dec 2007 | K070857 | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM | DZE Root-Form Endosseous Implant |
| 20 Dec 2007 | K072980 | NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 3 Aug 2007 | K071370 | NOBELACTIVE INTERNAL CONNECTION IMPLANT | DZE Root-Form Endosseous Implant |
| 11 Jul 2007 | K071182 | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | ELL Porcelain Teeth |
| 4 Apr 2007 | K070182 | ZYGOMA IMPLANT (IMMEDIATE FUNCTION) | DZE Root-Form Endosseous Implant |
| 6 Mar 2007 | K061971 | ZIRCONIA IMPLANT | DZE Root-Form Endosseous Implant |
| 27 Feb 2007 | K063592 | ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 | NHA Endosseous Dental Implant Abutment |
| 5 Jan 2007 | K063718 | SFB AND CFB IMPLANTS - 5.0 PLATFORM | DZE Root-Form Endosseous Implant |
| 19 Dec 2006 | K062936 | NOBELPERFECT CONICAL CONNECTION | DZE Root-Form Endosseous Implant |
| 6 Dec 2006 | K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION | DZE Root-Form Endosseous Implant |
| 29 Nov 2006 | K062749 | SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM | NHA Endosseous Dental Implant Abutment |
| 23 Aug 2006 | K061529 | PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 21 Aug 2006 | K061478 | PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS | NHA Endosseous Dental Implant Abutment |
| 11 Aug 2006 | K061477 | MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS | NHA Endosseous Dental Implant Abutment |
| 30 Jun 2006 | K061003 | SFB & CFB IMPLANTS | DZE Root-Form Endosseous Implant |
| 22 Feb 2006 | K053125 | PROCERA BRIDGE ZIRCONIA | NHA Endosseous Dental Implant Abutment |
| 22 Feb 2006 | K053068 | PROCERA BRIDGE LAMINATE, MODEL 40-4002 | NHA Endosseous Dental Implant Abutment |
| 22 Feb 2006 | K053050 | PROCERA BRIDGE ALUMINA | NHA Endosseous Dental Implant Abutment |
| 10 Feb 2006 | K053602 | PROCERA SOFTWARE, MODEL 33145 | NHA Endosseous Dental Implant Abutment |
| 27 Jan 2006 | K053091 | PROCERA IMPLANT BRIDGE ZIRCONIA | NHA Endosseous Dental Implant Abutment |
| 23 Dec 2005 | K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 | NHA Endosseous Dental Implant Abutment |
| 8 Jun 2005 | K050406 | NOBELSPEEDY IMPLANTS | DZE Root-Form Endosseous Implant |
| 19 May 2005 | K050705 | TIUNITE IMPLANTS | DZE Root-Form Endosseous Implant |
| 4 May 2005 | K050393 | THE GUIDED SURGERY CONCEPT | DZE Root-Form Endosseous Implant |
| 19 Apr 2005 | K050258 | GROOVY IMPLANTS | DZE Root-Form Endosseous Implant |
| 7 Apr 2005 | K050641 | ZYGOMA TIUNITE | NHA Endosseous Dental Implant Abutment |
| 1 Feb 2005 | K043312 | NOBELRONDO DENTAL CERAMIC - ZIRCONIA | EIH Porcelain Powder |
| 18 Nov 2004 | K043042 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 | NHA Endosseous Dental Implant Abutment |
| 28 May 2004 | K041283 | PROCERA BRIDGE ZIRCONIA | ELL Porcelain Teeth |
| 26 May 2004 | K041236 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 | NHA Endosseous Dental Implant Abutment |
| 6 Feb 2004 | K032562 | PROCEARA COPINGS AND PONTIC | ELL Porcelain Teeth |
| 6 Feb 2004 | K030685 | TEETH IN AN HOUR - ARK IMPLANT CONCEPT | DZE Root-Form Endosseous Implant |
| 3 Jul 2003 | K031070 | CARBON FIBER BRIDGE, MODEL 28757 | EBI Rebasing Repairing Relining Denture Resin |
| 2 Jul 2003 | K031719 | ESTHETIC ZIRCONIA ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 11 Oct 2002 | K022562 | VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: PaloDEx Group Oy (1), Digital Age Dental Laboratories, Ltd. (1).
Also lists devices cleared under other names
Nobel Biocare Services AG 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: Nobel Biocare Uas, Inc. (7), Elos Medtech Pinol A/S (6), Terrats Medical, S.L. (6), Steri-Oss, Inc. (5), Nobelpharma USA, Inc. (4), Zest Anchors, LLC (3), W&H Dentalwerk Buermoos GmbH (3), X-NAV Technologies, LLC. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Sep 2024 | K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 21 Dec 2023 | K231307 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 14 Aug 2023 | K231434 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 27 Oct 2022 | K222288 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 11 Mar 2022 | K212628 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 10 Dec 2021 | K212577 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 21 Jul 2021 | K193352 | AbutmentCAD | exocad GmbH | PNP Dental Abutment Design Software for Dental Laboratory |
| 19 Feb 2021 | K201860 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 23 Jan 2021 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | NPK Intraoral Synthetic Barrier |
| 21 May 2020 | K200662 | X-Guide® Surgical Navigation System | X-NAV Technologies, LLC. | PLV Dental Stereotaxic Instrument |
| 10 Feb 2020 | K191919 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 6 Feb 2020 | K191890 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 3 Feb 2020 | K192579 | X-Guide Surgical Navigation System | X-NAV Technologies, LLC. | PLV Dental Stereotaxic Instrument |
| 10 Nov 2019 | K191986 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 22 Aug 2019 | K181888 | Osstell Beacon | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 26 Jun 2019 | K190299 | Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2018 | K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG | NHA Endosseous Dental Implant Abutment |
| 18 Dec 2017 | K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | KaVo North America | MUH Digital Extraoral Source X-Ray System |
| 16 Nov 2017 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | EHD Extraoral with Timer X-Ray Unit |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 23 Nov 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Bürmoos GmbH | EBW Handpiece and Cord Foot Controller |
| 31 Jul 2015 | K142040 | OCS-B COLLAGEN | NIBEC Co Ltd | NPM Animal Source Bone Grafting Material |
| 24 Jul 2015 | K150295 | LOCATOR RTx | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
| 15 Aug 2014 | K140308 | MASTERSURG / EXPERTSURG | Kaltenbach & Voigt GmbH | EBW Handpiece and Cord Foot Controller |
| 16 Jan 2013 | K113246 | OCS-B | NIBEC Co Ltd | NPM Animal Source Bone Grafting Material |
| 15 Dec 2009 | K092214 | CHIROPRO L SYSTEM | Bien-Air Dental, SA | EBW Handpiece and Cord Foot Controller |
| 29 Jul 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | KMW Rotary Bone Cutting Handpiece |
| 3 Dec 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
| 3 May 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 27 May 2004 | K041275 | PROCERA ABUTMENT OCTAGON | Nobel Biocare Uas, Inc. | NHA Endosseous Dental Implant Abutment |
| 22 Apr 2004 | K033699 | LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 | Zest Anchors, LLC | DZE Root-Form Endosseous Implant |
| 26 Sep 2002 | K023113 | REPLACE TIUNITE ENDOSSEOUS IMPLANT | Nobel Biocare Uas, Inc. | DZE Root-Form Endosseous Implant |
| 29 May 2002 | K020646 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 | Nobel Biocare Uas, Inc. | DZE Root-Form Endosseous Implant |
| 28 Jun 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | W&H Dentalwerk Buermoos GmbH | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 30 Mar 2000 | K000018 | BRANEMARK NOVUM | Nobel Biocare Uas, Inc. | DZE Root-Form Endosseous Implant |
| 23 Nov 1999 | K992538 | AMORPHOUS DIAMOND COATED SCREW | Nobel Biocare Uas, Inc. | DZE Root-Form Endosseous Implant |
| 10 Dec 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | Bien Air USA, Inc. | EFB Dental Air-Powered Handpiece |
| 16 Oct 1997 | K970499 | BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM | Nobel Biocare Uas, Inc. | DZE Root-Form Endosseous Implant |
| 12 Sep 1997 | K972475 | AURADAPT AUBTMENT SYSTEM | Nobel Biocare Uas, Inc. | NHA Endosseous Dental Implant Abutment |
| 6 Aug 1997 | K972278 | CYTOPLAST REGENTEX TITANIUM 250 | Osteogenics Co. | LYC Synthetic Bone Grafting Material |
| 31 Mar 1997 | K964739 | STERI-OSS TIODIZED SCREW | Steri-Oss, Inc. | DZE Root-Form Endosseous Implant |
| 11 Mar 1997 | K964342 | CYTOPLAST GBR | Osteogenics Co. | LYC Synthetic Bone Grafting Material |
| 5 Mar 1997 | K964220 | REPLACE TITANIUM IMPLANT SYSTEM | Steri-Oss, Inc. | DZE Root-Form Endosseous Implant |
| 11 Feb 1997 | K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | Steri-Oss, Inc. | DZE Root-Form Endosseous Implant |
| 5 Aug 1994 | K913255 | CERAMIC(TM) ABUTMENT | Ceramic Core Corp. | DZE Root-Form Endosseous Implant |
| 10 Dec 1993 | K923695 | STERI-OSS SCREW STYLE CP TITANIUM IMPLANT | Steri-Oss, Inc. | DZE Root-Form Endosseous Implant |
| 20 Oct 1993 | K925767 | BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. | Nobelpharma USA, Inc. | DZE Root-Form Endosseous Implant |
| 22 Jul 1993 | K911592 | STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT | Steri-Oss, Inc. | DZE Root-Form Endosseous Implant |
| 20 Apr 1993 | K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS | Nobelpharma USA, Inc. | NHA Endosseous Dental Implant Abutment |
| 14 Apr 1993 | K925771 | BRANEMARK SYSTEM TITANIUM COVER SCREWS | Nobelpharma USA, Inc. | DZE Root-Form Endosseous Implant |
| 27 Aug 1992 | K905434 | ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 | Nobelpharma USA, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NOBEL BIOCARE ABFDA reg. 9611992 | GOTEBORG Vastra Gotaland, Sweden | Specification developer |
| NOBEL BIOCARE AB, PRODUKTIONFDA reg. 9611993 | KARLSKOGA Orebro, Sweden | Contract manufacturer, Manufacturer |
| Nobel Biocare c/o Medicim NVFDA reg. 3005739655 | Mechelen Antwerpen, Belgium | Complaint file establishment, Manufacturer |
| NOBEL BIOCARE DISTRIBUTION CENTER BVFDA reg. 3006540014 | Venlo Limburg, Netherlands | Complaint file establishment, Foreign exporter |
| NOBEL BIOCARE PROCERA, LLCFDA reg. 3005031178 | MAHWAH, NJ, United States | Complaint file establishment, Contract manufacturer |
| Nobel Biocare Services AGFDA reg. 3008693672 | Kloten Zurich, Switzerland | Specification developer |
| NOBEL BIOCARE USA, LLCFDA reg. 2027971 | YORBA LINDA, CA, United States | Contract manufacturer, Manufacturer |
Other names on FDA records
Nobel Biocare USA LLC · Nobel Biocare AB · Nobel Biocare AB Produktion · Nobel Biocare Procera, LLC · Nobel Biocare c/o Medicim NV · Nobel Biocare Distribution Center B.V.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030879). 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.