Manufacturer registered with FDA
Institut Straumann AG
BASEL, Switzerland. Lists 40 dental device types with FDA across 16 registered establishments, and holds 212 510(k) clearances as applicant.
- Device types listed
- 40
- Brands and models
- 356
- 510(k) clearances
- 2121990–2026
- Markets registered in
- 186,747 registrations outside the US
- Establishments
- 16Brazil, Canada, Switzerland +4
510(k) clearances per year, 1990–2026
Registered in 18 markets
Where regulators' registries name Institut Straumann 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 | Institut Straumann AG | 212 clearances | 1990–2026 | Below |
| Canada | Health Canada | Registration holder | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.INSTITUT STRAUMANN AG · ANTHOGYR · +2 | 2,844 | 1998–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Institut Straumann AGAnthogyr · MEDENTiKA GmbH · +2 | 1,124 | — | Pure Global AI |
| Brazil | ANVISA | Registration holder | JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.INSTITUT STRAUMANN AG · ANTHOGYR SAS · +2 | 496 | 2005–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.STRAUMANN VILLERET SA, · Straumann Villeret SA · +2 | 421 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | JJGC Industria e Comercio de Materiais Dentarios SAInstitut Straumann AG · Dental Wings Inc. · +2 | 289 | 2021–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | INSTITUT STRAUMANN AGJJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A. · ANTHOGYR S.A.S. · +2 | 267 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Institut Straumann AGJJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A. · Anthogyr · +2 | 264 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.INSTITUT STRAUMANN AG · JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A. · +2 | 226 | 2011–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INSTITUT STRAUMANN AGStraumann Villeret SA · Institut Straumann AG · +2 | 210 | 1996–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | anthogyrInstitut Straumann AG · Medentika GmbH · +1 | 204 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Institut Straumann AGAnthogyr · JJGC Industria e Comercio de Materiais Dentarios SA · +2 | 185 | 2005–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | ANTHOGYR S.A.Anthogyr SAS · Anthogyr S.A.S · +2 | 84 | 2001–2024 | Pure Global AI |
| Egypt | EDA | Manufacturer | JJGC Indústria e Comércio de Materiais Dentários SA,Anthogyr SAS, · JJGC Industria e Comercio de Materiais Dentarios S.A., · +2 | 53 | 2023–2026 | Pure Global AI |
| China | NMPA | Registration holder | 士卓曼研究院股份公司Institut Straumann AG安卓健股份有限公司 Anthogyr · 安卓健股份有限公司Anthogyr · +2 | 44 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Institut Straumann AGANTHOGYR · Dental Wings Inc. · +2 | 23 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Institut Straumann AG | 8 | 2025–2026 | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | JJGC Industria e Comercio de Materiais Dentarios S.A. | 5 | 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 Institut Straumann 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 componentsCARES AbutmentCARES TAN AbutmentCARES® Advanced BarCARES® Basic BarCARES® Complex BarCustom Abutment ASHSL abutments (Castable gold abutments)Medentibase abutmentsMedentiBase Titaniumbase abutment 170 moreMedentika Abutment ScrewsMedentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsMedentika Custom Abutments Gold HueMedentika PreFace CAD/CAM AbutmentsMedentika TiBase 3.5 mm CAD/CAM AbutmentsMedentika TiBase CAD/CAM AbutmentsMedentiloc abutmentsMulti-unit abutments and componentsMulti-unit TitaniumBase & Multi-unit Titanium CapNarrow Neck CrossFit (NNC) Gold Abutment for BridgesNC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type ANC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type BNC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type ANC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type BNC Closure & Fixation Cap, diameter 5.5mm, TiNC Closure CapNC Closure Cap for Fixation Cap, TiNC Closure Screw, H0NC Closure Screw, H0 (4-pack)NC Closure Screw, H0.5NC Closure Screw, H0.5 (4-pack)NC Fixation Cap, TiNC GOLD ABUTMENT FOR CROWNSNC Healing AbutmentNC Healing Abutment, bottleNC Healing Abutment, conicalNC Healing Abutment, customizableNC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type ANC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type BNC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type ANC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type BNC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type ANC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type BNC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type ANC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type BNC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 0, ZrO2NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 1, ZrO2NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 0, ZrO2NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 1, ZrO2NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 0, ZrO2NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 1, ZrO2NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 0, ZrO2NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 1, ZrO2NC Temporary Abutment, VITA CAD-Temp, PMMANC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TANNC Variobase Abutments, with screw, D 3.8mm, H 3.5mm, TANNC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TANNeodent Custom Abutments AS Ti, ASC ScrewsNeodent Dental Implant AbutmentsNeodent Dental ImplantsNeodent Gold Hue Custom AbutmentsNeodent Implant SystemNeodent Implant System GM Zygomatic Implant SystemNeodent Implant System Helix Short Implant SystemNeodent Implant System - CM Pro PEEK AbutmentNeodent Implant System - Easy PackNeodent Implant System - GM LineNeodent Implant System - GM Narrow Implant SystemNeodent Implant System - GM Titanium Base for BridgeNeodent Implant System - Mini Abutment 60Neodent Implant System - Temporary AbutmentsNeodent Implant System - Titanium Bases for CERECNeodent Implant System - Zirconia Implant SystemNeodent Implant System - Zygomatic Implants and AbutmentsNeodent Titanium Block for Medentika HolderNNC Basel Screw for Cementable AbutmentsNNC Cementable Abutment, 15 degree angle Type ANNC Cementable Abutment, 15 degree angle Type BNNC Cementable Abutment, straightNNC Closure CapNNC Closure Screw, H0NNC Closure Screw, H0 (4-pack)NNC Closure Screw, H0.5NNC Closure Screw, H0.5 (4-pack)NNC Healing CapNNC Protective CapNNC Solid AbutmentNNC Temporary Abutment, VITA CAD-Temp, PMMANNC Temporary CopingNNC Variobase Abutment, with screw, D 55mm, H 4mm, TANNNC Variobase Abutments, with screw, D 3.9mm, H 3.75mm, TANNNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TANNUVO CF Implant SystemNUVO IF Implant SystemPre-milled Abutment Blank for CARES®Preface abutmentRC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type ARC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type BRC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type ARC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type BRC Closure & Fixation Cap, diameter 5.5mm, TiRC Closure CapRC Closure Cap for Fixation Cap, TiRC Closure Screw, H0RC Closure Screw, H0 (4-pack)RC Closure Screw, H0.5RC Closure Screw, H0.5 (4-pack)RC Fixation Cap, TiRC Healing Abutment , bottleRC Healing Abutment, conicalRC Healing Abutment, conical diameter 4.5, H2RC Healing Abutment, conical diameter 4.5, H4RC Healing Abutment, conical diameter 4.5, H6RC Healing Abutment, conical diameter 6, H2RC Healing Abutment, conical diameter 6, H4RC Healing Abutment, conical diameter 6, H6RC Healing Abutment, customizableRC Temporary Abutment, VITA CAD-Temp, PMMARC Variobase Abutment, with screw, D 4.5mm, 3.5mm, TANRC Variobase Abutments, with screw, D 4.5mm, 3.5mm, TANRC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TANRN Closure CapRN closure Cap, H0, Ti (4-pack)RN Closure Cap, H1.5, Ti (4-pack)RN Gold Abutment, for BridgeRN Healing CapRN Temporary Abutment, VITA CAD-Temp, PMMARN Variobase Abutment, with screw, D 55mm, H 4mm, TANRN Variobase Abutments, with screw, D 55mm, H 4mm, TANRN Variobase®, for crown, with screw, D 55mm, H 6mm, TANRoxolid BLX ImplantsScrew Retained AbutmentsScrew-Retained AbutmentsSolid abutments (Prepable abutments)SRBB Bone LevelStandard abutmentsStrauamnn CARES Dolder Bar TitaniumStraumann Anatomic Healing AbutmentsStraumann BLX Gold AbutmentStraumann CARES AbutmentsStraumann CARES CS2 ScannerStraumann CARES Screw-Retained Bridge and Dolder BarStraumann CARES Screw-retained Bridge TitaniumStraumann CARES Screw-Retained Bridges and BarsStraumann CARES TAN AbutmentStraumann Ceramic Healing AbutmentsStraumann Custom Abutment ASSTRAUMANN DENTAL IMPLANT SYSTEMStraumann Immediate Temporary AbutmentsStraumann InLab Validated Workflow | 2006 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | BLC Implant 3.75mm RB, SLA® 18mm, Roxolid®BLC Implant 3.75mm RB, SLActive® 18mm, Roxolid®BLC ImplantsBLT 3.3 NC, SLActive 18mm, TiZr, LoximBLT 3.3mm NC, SLA 18mm, TiZr, LoximBLT 4.1 RC, SLActive 18mm, TiZr, LoximBLT 4.1mm RC, SLA 18mm, TiZr, LoximBLT 4.8 RC, SLActive 18mm, TiZr, LoximBLT 4.8mm RC, SLA 18mm, TiZr, LoximBone Level Implant TiZr RC 4.1mm L 8,10,12, 14mm 76 moreBone Level Implant TiZr RC 4.8mm L 8, 10, 12, 14mmMINICONE ImplantNeodent Dental Implant AbutmentsNeodent Dental ImplantsNeodent Implant SystemNeodent Implant System GM Zygomatic Implant SystemNeodent Implant System Helix Short Implant SystemNeodent Implant System - Acqua ImplantsNeodent Implant System - Easy PackNeodent Implant System - GM Helix 7Neodent Implant System - GM Helix LG ImplantsNeodent Implant System - GM LineNeodent Implant System - GM Narrow Implant SystemNeodent Implant System - Zirconia Implant SystemNeodent Implant System - Zygomatic Implants and AbutmentsNUVO CF Implant SystemNUVO IF Implant SystemRB/WB Screw-retained abutment, angled 17° & 30°, 4.6mmRC Temporary AbutmentRoxolid BLX ImplantsStraumann 4 mm Short ImplantsStraumann BLC ImplantsStraumann BLX 3.5 mm ImplantsStraumann BLX Implant SystemStraumann Bone Level Tapered ImplantStraumann Dental Implant SystemStraumann Narrow Neck CrossFit (NNC) Closure ScrewsStraumann Narrow Neck CrossFit (NNC) Dental Implant SystemStraumann Narrow Neck CrossFit (NNC) Gold Abutment for CrownStraumann Narrow Neck CrossFit (NNC) Healing CapsStraumann Narrow Neck CrossFit (NNC) Temporary AbutmentsStraumann PURE Ceramic ImplantsStraumann Roxolid SLA ImplantsStraumann TLC ImplantsStraumann® RidgeFit ImplantsTaper Effect RoxolidTitamax CMTLC ImplantsTLX Implant System033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr033.561S Standard Plus TL, RN, Ø4.1mm, SLActive 8mm, TiZr033.562S Standard Plus TL, RN, Ø4.1mm, SLActive 10mm, TiZr033.563S Standard Plus TL, RN, Ø4.1mm, SLActive 12mm, TiZr033.564S Standard Plus TL, RN, Ø4.1mm, SLActive 14mm, TiZr033.571S Tapered Effect, TL, RN, Ø4.1mm, SLActive 8mm, TiZr033.572S Tapered Effect, TL, RN, Ø4.1mm, SLActive 10mm, TiZr033.573S Tapered Effect, TL, RN, Ø4.1mm, SLActive 12mm, TiZr033.574S Tapered Effect, TL, Ø4.1mm, SLActive 14mm, TiZr033.580S Standard TL, RN, Ø4.8mm, SLActive 6mm, TiZr033.581S Standard TL, RN, Ø4.8mm, SLActive 8mm, TiZr033.582S Standard TL, RN, Ø4.8mm, SLActive 10mm, TiZr033.583S Standard TL, RN, Ø4.8mm, SLActive 12mm, TiZr033.584S Standard TL, RN, Ø4.8mm, SLActive 14mm, TiZr033.590S Standard Plus TL, RN, Ø4.8mm, SLActive 6mm, TiZr033.591S Standard Plus TL, RN, Ø4.8mm, SLActive 8mm, TiZr033.592S Standard Plus TL, RN, Ø4.8mm, SLActive 10mm, TiZr033.593S Standard Plus TL, RN, Ø4.8mm, SLActive 12mm, TiZr033.594S Standard Plus TL, RN, Ø4.8mm, SLActive 14mm, TiZr033.600S Standard TL, WN Ø4.8mm, SLActive 6mm, TiZr033.601S Standard TL, WN Ø4.8mm, SLActive 8mm, TiZr033.602S Standard TL, WN Ø4.8mm, SLActive 10mm, TiZr033.603S Standard TL, WN Ø4.8mm, SLActive 12mm, TiZr033.610S Standard Plus TL, WN Ø4.8mm, SLActive 6mm, TiZr033.611S Standard Plus TL, WN Ø4.8mm, SLActive 8mm, TiZr033.612S Standard Plus TL, WN Ø4.8mm, SLActive 10mm, TiZr033.613S Standard Plus TL, WN Ø4.8mm, SLActive 12mm, TiZr033.614S Standard Plus TL, WN Ø4.8mm, SLActive 14mm, TiZr033.622S Tapered Effect, TL, WN, Ø4.1mm, SLActive 10mm, TiZr033.623S Tapered Effect, TL, WN, Ø4.1mm, SLActive 12mm, TiZr033.624S Tapered Effect, TL, WN, Ø4.1mm, SLActive 14mm, TiZr | 1999 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | MedentiBase Titaniumbase abutmentMulti-unit TitaniumBase & Multi-unit Titanium CapNeodent Titanium Block for Medentika HolderPre-milled Abutment Blank for CARES®Preface abutmentStraumann CARES Visual and Nova Dental CADStraumann InLab Validated WorkflowStraumann Pre-Milled Abutment Blank for Medentika HolderStraumann Variobase CTI-Forms abutment 2 moreTitanium base 2nd generationTitanium base ASC Flex | 2018 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | IPS Empress CADn!ce Crownn!ce Inlayn!ce Onlayn!ce Partial Crownn!ce Veneern!ce® for PlanmillPorcelain powderStraumann Dental Implant Systemzerion and glass ceramic restorations 1 morezerion HT elements | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Accesories | 2007 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | AS200EAS260CARES AbutmentDI-1DWOSS300WSIRIOSSmart DesignST 300EST200E 3 moreStraumann CARES CS2 ScannerStraumann CARES VisualStraumann CARES Visual Chairside | 2008 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | MEMFIXNeodent Graft Screw | 1999 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Straumann Dental Implant System | 2011 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Straumann Dental Implant System | 1999 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | REF03 ClearCorrect System Aligners (Multi-layer)REF05 ClearCorrect System Aligner (Single Layer) | 2020 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | polycon ae restoration | 2010 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Maker | CONTRE-ANGLESHAND-PIECESIMPULSION CONTRA-ANGLESMONT BLANC IMPLANTOLOGYMONT BLANC OMNIPRATIC | 2021 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | ticon and coron restorations | 2008 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Straumann Dental Implant System | 2011 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Neodent Implant for Orthodontic AnchorageStraumann Dental Implant System | 2008 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | EUROPOSTEXCELPOST | 2021 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | coDiagnostiXSurgical Guide with Cut Profile | 2021 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Equator AttachmentNovalocOptiloc | 2021 |
| Preformed BarEHO · Class 1 | — | Maker | Straumann Dental Implant System | 2011 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2021 |
| Preformed AnchorEJX · Class 1 | — | Maker | Straumann Dental Implant System | 2011 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | EUROPOSTEXCELPOSTFIBIOFLEXI-POSTS | 2021 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | Straumann Dental Implant System | 2011 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Straumann Dental Implant System | 2011 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | REF04 ClearCorrect System Retainer | 2023 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Straumann BoneCeramic | 2021 |
| Dental Biologic MaterialNQA · Class 3 | — | Maker | STRAUMANN EMDOGAIN | 2006 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | REF02 ClearCorrect System Engager TemplateREF06 ClearCorrect System Engager Template | 2023 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | — | 2021 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Neodent Dental Hand Instruments | 2021 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | IMPLANTEOIMPLANTEO LED | 2021 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | SURGERY MONTBLANC CONTRA-ANGLESURGERY MONTBLANC HANDPIECE | 2021 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | ASPEO | 2021 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Neodent Retractor | 2021 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Anthogyr ACCESSOIRIESAnthogyr ATD AUTOMATIC BRIDGE REMOVERAnthogyr SAFE RELAXAnthogyr SAFE REMOVER | 2021 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Neodent Curette | 2021 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Chisel | 2021 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | MembraGelSynthetic Barrier, intraoral | 2010 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | Straumann Membrane Max | 2014 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | Straumann XenoGraft | 2014 |
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 Institut Straumann AG as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Jul 2026 | K261147 | Neodent Implant System - NeoConvert Fit | NHA Endosseous Dental Implant Abutment |
| 15 Jun 2026 | K253922 | Neodent Scannable Healing Abutment | NHA Endosseous Dental Implant Abutment |
| 7 May 2026 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | NHA Endosseous Dental Implant Abutment |
| 10 Mar 2026 | K252168 | Straumann® BLC Implants - Indication Widening | DZE Root-Form Endosseous Implant |
| 22 Jan 2026 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2026 | K252727 | Neodent InLab Validated Workflow | NHA Endosseous Dental Implant Abutment |
| 23 Dec 2025 | K253341 | Custom Abutments AS | NHA Endosseous Dental Implant Abutment |
| 12 Dec 2025 | K252090 | Pterygoid Indication for GM Helix Implants | DZE Root-Form Endosseous Implant |
| 18 Aug 2025 | K250271 | Neodent Implant System - Zirconia Implant System | DZE Root-Form Endosseous Implant |
| 12 Aug 2025 | K250294 | Straumann® RidgeFit Implants | DZE Root-Form Endosseous Implant |
| 22 Apr 2025 | K242542 | Medentika CAD/CAM Abutments | NHA Endosseous Dental Implant Abutment |
| 21 Feb 2025 | K243278 | Custom Abutments | NHA Endosseous Dental Implant Abutment |
| 19 Feb 2025 | K243478 | Straumann InLab Validated Workflow | NHA Endosseous Dental Implant Abutment |
| 26 Dec 2024 | K233252 | Straumann CARES Visual and Nova Dental CAD | PNP Dental Abutment Design Software for Dental Laboratory |
| 10 Dec 2024 | K241391 | Straumann® PURE Ceramic Implants | DZE Root-Form Endosseous Implant |
| 11 Nov 2024 | K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | NHA Endosseous Dental Implant Abutment |
| 2 May 2024 | K233857 | Neodent Implant System Custom Abutments | NHA Endosseous Dental Implant Abutment |
| 15 Apr 2024 | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | NHA Endosseous Dental Implant Abutment |
| 20 Mar 2024 | K234049 | Straumann® BLC and TLC Implants - Line extension | DZE Root-Form Endosseous Implant |
| 4 Jan 2024 | K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | NHA Endosseous Dental Implant Abutment |
| 13 Dec 2023 | K231803 | Neodent Implant System - Zirconia Implant System | NHA Endosseous Dental Implant Abutment |
| 31 Oct 2023 | K232099 | Neodent Implant System - GM Zygomatic Implant System | DZE Root-Form Endosseous Implant |
| 16 Oct 2023 | K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | DZE Root-Form Endosseous Implant |
| 14 Sep 2023 | K230108 | Straumann® BLC and TLC Implants | DZE Root-Form Endosseous Implant |
| 14 Jul 2023 | K222026 | Neodent Implant System - Zirconia Implant System | NHA Endosseous Dental Implant Abutment |
| 23 Jun 2023 | K223638 | Neodent Implant System - Helix Short Implant System | DZE Root-Form Endosseous Implant |
| 22 Jun 2023 | K223083 | Straumann SLActive labeling changes | DZE Root-Form Endosseous Implant |
| 15 May 2023 | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | NHA Endosseous Dental Implant Abutment |
| 5 Oct 2022 | K220140 | ClearCorrect System | NXC Sequential Aligner |
| 6 Sep 2022 | K220251 | Neodent Implant System - GM Narrow Implant System | DZE Root-Form Endosseous Implant |
| 16 Jun 2022 | K220878 | Straumann TLX Variobase C | NHA Endosseous Dental Implant Abutment |
| 2 Jun 2022 | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | NHA Endosseous Dental Implant Abutment |
| 8 Apr 2022 | K213063 | TLX SRAs and TLX Gold Abutments | NHA Endosseous Dental Implant Abutment |
| 28 Jan 2022 | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | DZE Root-Form Endosseous Implant |
| 9 Oct 2021 | K203750 | Straumann CARES P-Series CAD/CAM System | NHA Endosseous Dental Implant Abutment |
| 13 Aug 2021 | K210336 | Neodent Implant System - Zirconia Implant System | DZE Root-Form Endosseous Implant |
| 6 Aug 2021 | K210320 | ClearCorrect System | NXC Sequential Aligner |
| 2 Aug 2021 | K203542 | Neodent Implant System - Mini Abutment 60° | NHA Endosseous Dental Implant Abutment |
| 8 Jul 2021 | K211052 | Straumann RidgeFit Implants | DZE Root-Form Endosseous Implant |
| 6 Jul 2021 | K203309 | NUVO CF Implant System | DZE Root-Form Endosseous Implant |
| 23 Jun 2021 | K203456 | Straumann CARES M-Series CAD/CAM System | NHA Endosseous Dental Implant Abutment |
| 21 Jun 2021 | K210855 | Straumann BLX Implant System | DZE Root-Form Endosseous Implant |
| 21 Jun 2021 | K193301 | coDiagnostiX | DZJ Manual Wire Driver and Bone Drill |
| 18 Mar 2021 | K201681 | Straumann Immediate Temporary Abutments | NHA Endosseous Dental Implant Abutment |
| 15 Mar 2021 | K203382 | Neodent Implant System-Easy Pack | DZE Root-Form Endosseous Implant |
| 12 Feb 2021 | K203355 | Straumann TLX Novaloc and Cementable Abutments | NHA Endosseous Dental Implant Abutment |
| 12 Feb 2021 | K192742 | Straumann Variobase C | NHA Endosseous Dental Implant Abutment |
| 8 Feb 2021 | K202942 | Straumann 4 mm Short Implants | DZE Root-Form Endosseous Implant |
| 29 Jan 2021 | K202282 | Neodent Implant System - Zirconia Implant System | NHA Endosseous Dental Implant Abutment |
| 22 Dec 2020 | K201491 | Neodent Implant System - Zirconia Implant System | DZE Root-Form Endosseous Implant |
| 8 Dec 2020 | K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | NHA Endosseous Dental Implant Abutment |
| 16 Oct 2020 | K200906 | MINICONE Implant | DZE Root-Form Endosseous Implant |
| 24 Sep 2020 | K201051 | Straumann BoneCeramic | LYC Synthetic Bone Grafting Material |
| 4 Sep 2020 | K201225 | Neodent Implant System - GM Helix Implants 7.0 | DZE Root-Form Endosseous Implant |
| 20 Aug 2020 | K200586 | Straumann TLX Implant System | DZE Root-Form Endosseous Implant |
| 13 Aug 2020 | K193046 | Straumann® Retentive System Novaloc TiN Abutments | NHA Endosseous Dental Implant Abutment |
| 18 Jun 2020 | K193234 | NUVO IF Implant System | DZE Root-Form Endosseous Implant |
| 28 Apr 2020 | K193592 | Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants | DZE Root-Form Endosseous Implant |
| 6 Apr 2020 | K192401 | Straumann Screw-Retained Abutments | NHA Endosseous Dental Implant Abutment |
| 6 Jan 2020 | K191123 | Multi-unit Abutments | NHA Endosseous Dental Implant Abutment |
| 3 Jan 2020 | K192893 | Straumann Ceramic Healing Abutments | NHA Endosseous Dental Implant Abutment |
| 27 Dec 2019 | K191256 | Straumann BLX Ø3.5 mm Implants | DZE Root-Form Endosseous Implant |
| 19 Dec 2019 | K192229 | Neodent Implant System- GM Titanium Base for Bridge | NHA Endosseous Dental Implant Abutment |
| 9 Dec 2019 | K191895 | Straumann Mini Implants | DZE Root-Form Endosseous Implant |
| 5 Dec 2019 | K191191 | Neodent Implant System - Temporary Abutments | NHA Endosseous Dental Implant Abutment |
| 9 Nov 2019 | K190958 | Neodent Implant System | DZE Root-Form Endosseous Implant |
| 28 Oct 2019 | K192029 | Straumann PUREloc abutments | NHA Endosseous Dental Implant Abutment |
| 11 Jul 2019 | K190718 | Zygomatic Implants | DZE Root-Form Endosseous Implant |
| 28 Jun 2019 | K190654 | Straumann CI RD Ceramic Healing Caps | NHA Endosseous Dental Implant Abutment |
| 26 Jun 2019 | K190097 | Straumann CARES Screw-Retained Bridges and Bars | NHA Endosseous Dental Implant Abutment |
| 17 Jun 2019 | K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | DZE Root-Form Endosseous Implant |
| 17 Apr 2019 | K190082 | Straumann BLX Variobase Abutment | NHA Endosseous Dental Implant Abutment |
| 8 Apr 2019 | K190040 | Straumann BLX Line Extension - New Abutments | NHA Endosseous Dental Implant Abutment |
| 18 Jan 2019 | K182620 | MRI Compatibility for Existing Neodent Implant System | DZE Root-Form Endosseous Implant |
| 7 Jan 2019 | K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | NHA Endosseous Dental Implant Abutment |
| 4 Jan 2019 | K180477 | Straumann PURE Ceramic Implant System | DZE Root-Form Endosseous Implant |
| 28 Dec 2018 | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | DZE Root-Form Endosseous Implant |
| 19 Oct 2018 | K173594 | Straumann cerabone | NPM Animal Source Bone Grafting Material |
| 5 Oct 2018 | K173945 | Straumann SC Variobase Abutments | NHA Endosseous Dental Implant Abutment |
| 30 Aug 2018 | K180536 | Neodent Implant System GM Line | DZE Root-Form Endosseous Implant |
| 17 Jul 2018 | K173968 | Straumann Variobase for Bridge/Bar Cylindrical | NHA Endosseous Dental Implant Abutment |
| 9 Jul 2018 | K173562 | Straumann Jason Membrane | NPL Intraoral Animal Source Barrier |
| 5 Jun 2018 | K173961 | Straumann BLX Implant System | DZE Root-Form Endosseous Implant |
| 20 Apr 2018 | K173902 | Neodent Implant System GM Line | NHA Endosseous Dental Implant Abutment |
| 30 Mar 2018 | K173379 | Straumann Variobase for Crown AS | NHA Endosseous Dental Implant Abutment |
| 22 Feb 2018 | K171649 | Straumann CARES M-Series CAD/CAM System | NHA Endosseous Dental Implant Abutment |
| 19 Jan 2018 | K171784 | Straumann Dental Implant System | DZE Root-Form Endosseous Implant |
| 3 Jan 2018 | K172798 | Straumann CARES Abutments CoCr | NHA Endosseous Dental Implant Abutment |
| 1 Dec 2017 | K171773 | Straumann n!ce Glass Ceramic A14 Blocks | NHA Endosseous Dental Implant Abutment |
| 14 Nov 2017 | K173410 | n!ce for Planmill | EIH Porcelain Powder |
| 2 Nov 2017 | K170080 | Neodent Implant System - CM Pro PEEK Abutment | NHA Endosseous Dental Implant Abutment |
| 22 Sep 2017 | K162848 | Straumann CARES Golden Ti/TiN Abutments | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2017 | K170838 | Medentika CAD/CAM TiBases | NHA Endosseous Dental Implant Abutment |
| 14 Jul 2017 | K163194 | Neodent Implant System - GM Line | DZE Root-Form Endosseous Implant |
| 15 Jun 2017 | K161177 | Axiom PX | DZE Root-Form Endosseous Implant |
| 7 Jun 2017 | K170356 | Straumann Variobase Abutments | NHA Endosseous Dental Implant Abutment |
| 7 Jun 2017 | K170354 | Straumann Variobase Abutments | NHA Endosseous Dental Implant Abutment |
| 8 Mar 2017 | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment | DZE Root-Form Endosseous Implant |
| 2 Mar 2017 | K170420 | n!ce Glass Ceramic Blocks for Amann Girrbach | EIH Porcelain Powder |
| 7 Oct 2016 | K161677 | Straumann Sterile Healing Solution | NHA Endosseous Dental Implant Abutment |
| 16 Sep 2016 | K160964 | Neodent Implant System - Titanium Base for CEREC | NHA Endosseous Dental Implant Abutment |
| 16 Sep 2016 | K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, | EIH Porcelain Powder |
| 23 Mar 2016 | K153758 | Straumann Bone Level Tapered Implants | DZE Root-Form Endosseous Implant |
| 4 Mar 2016 | K151590 | Straumann RN Gold Abutment for Bridge | NHA Endosseous Dental Implant Abutment |
| 11 Jan 2016 | K151328 | PURE Ceramic Implants | DZE Root-Form Endosseous Implant |
| 23 Oct 2015 | K150203 | Medentika CAD/CAM Abutments | NHA Endosseous Dental Implant Abutment |
| 16 Sep 2015 | K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | NHA Endosseous Dental Implant Abutment |
| 11 Sep 2015 | K151324 | Straumann Variobase for CEREC | NHA Endosseous Dental Implant Abutment |
| 10 Aug 2015 | K151247 | NC Straumann Screw Retained Abutments | NHA Endosseous Dental Implant Abutment |
| 10 Aug 2015 | K150814 | Straumann Screw-Retained Abutment | NHA Endosseous Dental Implant Abutment |
| 5 Aug 2015 | K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges | NHA Endosseous Dental Implant Abutment |
| 24 Jul 2015 | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | DZE Root-Form Endosseous Implant |
| 20 Feb 2015 | K142167 | MEDENTIKA ABUTMENT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 9 Jan 2015 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit | NHA Endosseous Dental Implant Abutment |
| 17 Sep 2014 | K141450 | AXIOM 2.8 | DZE Root-Form Endosseous Implant |
| 20 Aug 2014 | K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT | DZE Root-Form Endosseous Implant |
| 14 Aug 2014 | K140737 | STRAUMANN CARES SCREW RETAINED BARS/BRIDGE | NHA Endosseous Dental Implant Abutment |
| 7 Aug 2014 | K141871 | Straumann Bone Level NC Angled Screw Retained Abutments | NHA Endosseous Dental Implant Abutment |
| 17 Apr 2014 | K133421 | STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW | NHA Endosseous Dental Implant Abutment |
| 21 Feb 2014 | K132219 | STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, | NHA Endosseous Dental Implant Abutment |
| 21 Feb 2014 | K131066 | AXIOM REG | DZE Root-Form Endosseous Implant |
| 15 Jan 2014 | K132844 | STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES | NHA Endosseous Dental Implant Abutment |
| 28 Jun 2013 | K130808 | STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS | NHA Endosseous Dental Implant Abutment |
| 29 Apr 2013 | K130222 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Apr 2013 | K123784 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Dec 2012 | K120822 | STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST | NHA Endosseous Dental Implant Abutment |
| 12 Dec 2012 | K122855 | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 2 Nov 2012 | K122192 | NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM | NHA Endosseous Dental Implant Abutment |
| 6 Jun 2012 | K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM | DZE Root-Form Endosseous Implant |
| 19 Mar 2012 | K113618 | CLEARCORRECT SYSTEM | NXC Sequential Aligner |
| 27 Jan 2012 | K113606 | NNC GOLD ABUTMENT FOR BRIDGES | NHA Endosseous Dental Implant Abutment |
| 13 Jan 2012 | K113410 | NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 28 Dec 2011 | K113283 | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 16 Nov 2011 | K112280 | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM | NHA Endosseous Dental Implant Abutment |
| 7 Oct 2011 | K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 3 Oct 2011 | K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 12 Sep 2011 | K111724 | STRAUMANN TIBRUSH | ELB Rotary Scaler |
| 12 Aug 2011 | K110580 | NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 23 Mar 2011 | K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT | EBW Handpiece and Cord Foot Controller |
| 11 Mar 2011 | K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM | DZE Root-Form Endosseous Implant |
| 13 Dec 2010 | K101465 | STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR | NHA Endosseous Dental Implant Abutment |
| 3 Mar 2010 | K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | EFA Dental Belt and/or Gear Driven Handpiece |
| 12 Feb 2010 | K093027 | STRAUMANN RC TEMPORARY ABUTMENTS | DZE Root-Form Endosseous Implant |
| 22 Dec 2009 | K091701 | STRAUMANN MODIFIED DENTAL ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 18 Dec 2009 | K093113 | ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 15 Dec 2009 | K092814 | STRAUMANN DENTAL ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 22 May 2009 | K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | EFA Dental Belt and/or Gear Driven Handpiece |
| 22 May 2009 | K082111 | STRAUMANN MEMBRAGEL | NPK Intraoral Synthetic Barrier |
| 26 Feb 2009 | K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS | DZE Root-Form Endosseous Implant |
| 26 Feb 2009 | K083550 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Feb 2009 | K081419 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 6 Feb 2009 | K082556 | CLEARCORRECT | NXC Sequential Aligner |
| 21 Oct 2008 | K082532 | STRAUMANN GUIDED INSTRUMENTS | DZI Powered Bone Drill |
| 17 Oct 2008 | K082545 | STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 1 Oct 2008 | K082764 | STRAUMANN WN CARES TITANIUM ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 23 May 2008 | K081186 | CONCAVE RN HEALING CAP | NHA Endosseous Dental Implant Abutment |
| 2 May 2008 | K081005 | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 30 Apr 2008 | K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS | NHA Endosseous Dental Implant Abutment |
| 7 Mar 2008 | K080286 | CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS | NHA Endosseous Dental Implant Abutment |
| 22 Jan 2008 | K073628 | SYNOCTA ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 15 Oct 2007 | K071888 | STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES | NHA Endosseous Dental Implant Abutment |
| 12 Oct 2007 | K072679 | P.004 ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 26 Sep 2007 | K072497 | P.004 NC GOLD ABUTMENT FOR CROWNS | NHA Endosseous Dental Implant Abutment |
| 26 Sep 2007 | K071357 | P.004 NC ANATOMIC ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 20 Sep 2007 | K070478 | P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) | NHA Endosseous Dental Implant Abutment |
| 11 Sep 2007 | K072151 | P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 31 Aug 2007 | K070549 | STRAUMANN P.004 RC GOLD ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 15 Aug 2007 | K072071 | STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS | NHA Endosseous Dental Implant Abutment |
| 11 Jul 2007 | K071585 | P.004 HEALING ABUTMENTS AND CLOSURE SCREWS | NHA Endosseous Dental Implant Abutment |
| 29 Jun 2007 | K070744 | NARROW NECK TEMPORARY COPING | NHA Endosseous Dental Implant Abutment |
| 10 May 2007 | K063789 | WN SYNOCTA GOLD ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 12 Apr 2007 | K061277 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING | NHA Endosseous Dental Implant Abutment |
| 20 Oct 2006 | K062129 | P.0004 IMPLANTS | DZE Root-Form Endosseous Implant |
| 24 Aug 2006 | K060958 | STRAUMANN NARROW NECK IMPLANTS | DZE Root-Form Endosseous Implant |
| 11 Aug 2006 | K061176 | STRAUMANN DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 27 Feb 2006 | K053088 | SLACTIVE IMPLANTS | DZE Root-Form Endosseous Implant |
| 3 Feb 2006 | K060062 | STRAUMANN ORTHOSYSTEM | OAT Orthodontic Endosseous Implant |
| 3 Jan 2006 | K052272 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE | NHA Endosseous Dental Implant Abutment |
| 7 Jul 2005 | K051717 | RN SYNOCTA TEMPORARY MESO ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 5 Apr 2005 | K050515 | BONE BLOCK FIXATION SET | DZL Intraosseous Fixation Screw |
| 14 Dec 2004 | K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | EJI Cartridge Syringe |
| 23 Sep 2004 | K041279 | IMPLANTEO IMPLANTOLOGY MOTOR | EKX Ac-Powered Direct Drive Handpiece |
| 30 Jun 2004 | K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | EFA Dental Belt and/or Gear Driven Handpiece |
| 30 Jun 2004 | K033984 | STRAUMANN DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 24 May 2004 | K041295 | RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT | NHA Endosseous Dental Implant Abutment |
| 18 Mar 2004 | K040539 | ELLIPTIC MATRIX | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2004 | K033922 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Oct 2003 | K033243 | ITI SYNOCTA MESO ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 27 Aug 2003 | K032498 | DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) | NHA Endosseous Dental Implant Abutment |
| 7 Jul 2003 | K031055 | ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 31 Mar 2003 | K030007 | ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 19 Sep 2002 | K022859 | ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Feb 2002 | K020096 | ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 5 Feb 2002 | K013891 | SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT | DZE Root-Form Endosseous Implant |
| 19 Dec 2001 | K013798 | PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 23 Aug 2001 | K011698 | STRAUMANN GBR SYSTEM | JEY Bone Plate |
| 22 Aug 2001 | K012757 | ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Aug 2001 | K003552 | ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 May 2001 | K010291 | ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Mar 2001 | K003271 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 1 Nov 2000 | K002374 | ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT | DZE Root-Form Endosseous Implant |
| 17 Mar 2000 | K994119 | SYNOCTA ANGLED ABUTMENTS | DZE Root-Form Endosseous Implant |
| 20 Jul 1999 | K990342 | SYNOCTA PROSTHETICS | DZE Root-Form Endosseous Implant |
| 13 May 1999 | K984104 | ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Mar 1999 | K983742 | ITI DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 30 Sep 1998 | K982509 | ORTHO IMPLANT AND ACCESSORIES | OAT Orthodontic Endosseous Implant |
| 2 Dec 1997 | K973353 | BONDING BASE | DZE Root-Form Endosseous Implant |
| 30 Jun 1997 | K971578 | ENDOSSEOUS DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 7 Oct 1996 | K962647 | ANGLED ABUTMENT | DZE Root-Form Endosseous Implant |
| 13 Feb 1990 | K894595 | BONEFIT R SCREW IMPLANTS | DZE Root-Form Endosseous Implant |
| 13 Feb 1990 | K894594 | BONEFIT HOLLOW SCREW IMPLANTS | DZE Root-Form Endosseous Implant |
| 13 Feb 1990 | K894593 | BONEFIT HOLLOW CYLINDER IMPLANTS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (6), botiss biomaterials GmbH (2), SMD Dental Laboratory (1), Kelsey Dental LLC (1).
Also lists devices cleared under other names
Institut Straumann 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: Jjgc Industria E Comercio DE Materiais Dentarios S (11), The Straumann Co. (6), Jjgc Indústria E Comércia DE Materiais Dentários S.A. (2), Straumann USA, LLC (On Behalf of Institut Straumann Ag) (2), Dentsply Sirona, Inc. (2), Neodent USA, Inc. (1), Jj Industria E Comercio DE Materiais Dentarios SA (1), NIBEC Co Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 May 2025 | K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | NHA Endosseous Dental Implant Abutment |
| 4 Dec 2024 | K242686 | Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | NHA Endosseous Dental Implant Abutment |
| 19 Aug 2020 | K200597 | Straumann BLX Gold Abutments | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | NHA Endosseous Dental Implant Abutment |
| 27 Nov 2017 | K171757 | Straumann Screw Retained Abutments | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | NHA Endosseous Dental Implant Abutment |
| 15 Apr 2016 | K153624 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | NHA Endosseous Dental Implant Abutment |
| 20 Jul 2015 | K141777 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE Root-Form Endosseous Implant |
| 13 Jul 2015 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | NHA Endosseous Dental Implant Abutment |
| 15 Jun 2015 | K150199 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE Root-Form Endosseous Implant |
| 23 Apr 2015 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE Root-Form Endosseous Implant |
| 22 Aug 2014 | K133592 | NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM | Neodent USA, Inc. | DZE Root-Form Endosseous Implant |
| 25 Feb 2014 | K133696 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | NHA Endosseous Dental Implant Abutment |
| 24 Feb 2014 | K133510 | NEODENT IMPLANT SYSTEM | Jj Industria E Comercio DE Materiais Dentarios SA | DZE Root-Form Endosseous Implant |
| 17 May 2013 | K123022 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE Root-Form Endosseous Implant |
| 16 Jan 2013 | K113246 | OCS-B | NIBEC Co Ltd | NPM Animal Source Bone Grafting Material |
| 17 Feb 2012 | K111421 | SIRONA DENTAL CAD/CAM SYSTEM | Dentsply Sirona, Inc. | NHA Endosseous Dental Implant Abutment |
| 17 Oct 2011 | K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR | Wieland Dental + Technik GmbH & Co. KG | EIH Porcelain Powder |
| 4 May 2011 | K102307 | GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS | GENOSS Co., Ltd. | NPL Intraoral Animal Source Barrier |
| 23 Feb 2011 | K102769 | NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE | Jjgc Industria E Comercio DE Materiais Dentarios S | OAT Orthodontic Endosseous Implant |
| 14 Feb 2011 | K103084 | NEODENT GRAFT SCREW | Jjgc Industria E Comercio DE Materiais Dentarios S | DZL Intraosseous Fixation Screw |
| 26 Jan 2011 | K101945 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE Root-Form Endosseous Implant |
| 22 Oct 2010 | K100152 | SIRONA CAD/CAM SYSTEM | Dentsply Sirona, Inc. | NHA Endosseous Dental Implant Abutment |
| 11 Aug 2010 | K102128 | VITABLOCS | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH Porcelain Powder |
| 2 Aug 2010 | K101207 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE Root-Form Endosseous Implant |
| 26 Sep 2007 | K071919 | P.004 ABUTMENTS | Straumann USA (On Behalf of Institut Straumann Ag) | NHA Endosseous Dental Implant Abutment |
| 21 Aug 2007 | K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | Merz Dental GmbH | EBG Resin Temporary Crown and Bridge |
| 6 Oct 2006 | K061804 | ZERION ALPHA, ; ZERION BETA | Etkon International GmbH | EIH Porcelain Powder |
| 14 Oct 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | Ivoclar Vivadent, AG | EIH Porcelain Powder |
| 23 Jul 2004 | K041070 | STRAUMANN TEMPORARY COPING | The Straumann Co. | NHA Endosseous Dental Implant Abutment |
| 3 Jul 2002 | K020431 | FIBIOCORE | Est. Anthogyr | ELR Root Canal Post |
| 11 May 1998 | K980986 | PROCAD | Ivoclar USA, Inc. | EIH Porcelain Powder |
| 15 Aug 1996 | K962023 | PLASTIC PROTECTION HEALING CAPS | The Straumann Co. | DZE Root-Form Endosseous Implant |
| 18 Jun 1996 | K960634 | TITANIUM HEALING CAPS | The Straumann Co. | DZE Root-Form Endosseous Implant |
| 23 Jan 1996 | K955369 | MEMFIX | The Straumann Co. | DZL Intraosseous Fixation Screw |
| 24 Mar 1995 | K943720 | ITI TRANSVERSAL SCREWING SYSTEM | The Straumann Co. | DZE Root-Form Endosseous Implant |
| 26 Apr 1994 | K931993 | ITI DISTANCE SYSTEM | The Straumann Co. | DZE Root-Form Endosseous Implant |
| 2 Feb 1990 | K894844 | BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS | Straumann Institute, Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ANTHOGYRFDA reg. 8020776 | SALLANCHES Haute-Savoie, France | Manufacturer |
| BIORA ABFDA reg. 9612827 | MALMO Skane, Sweden | Foreign exporter, Manufacturer, Repacker / relabeler |
| ClearCorrect , LLCFDA reg. 3007130440 | Round Rock, TX, United States | Manufacturer |
| DENTAL WINGS GMBHFDA reg. 3010377510 | Chemnitz Saxony, Germany | Manufacturer, Specification developer |
| Dental Wings Inc.FDA reg. 3006945044 | Montreal Quebec, Canada | Contract manufacturer, Manufacturer |
| etkon GMBHFDA reg. 3011221537 | Markkleeberg Saxony, Germany | Manufacturer |
| etkon GMBHFDA reg. 3005106408 | GRAEFELFING Bavaria, Germany | Manufacturer |
| INSTITUT STRAUMANN AGFDA reg. 9613348 | BASEL Basel-Stadt, Switzerland | Complaint file establishment, Foreign exporter, Specification developer |
| JJGC Industria e Comercio de Materiais Dentarios SAFDA reg. 3008261720 | Curitiba Parana, Brazil | Contract manufacturer, Manufacturer |
| Medentika GmbHFDA reg. 3026444199 | Calw Baden-Wurttemberg, Germany | Manufacturer |
| MEDENTIKA GMBHFDA reg. 3008770646 | Huegelsheim Baden-Wurttemberg, Germany | Specification developer |
| Straumann Manufacturing, Inc.FDA reg. 3024185724 | Mansfield, TX, United States | Contract manufacturer, Manufacturer |
| Straumann Manufacturing, Inc.FDA reg. 3033781108 | Andover, MA, United States | Manufacturer |
| Straumann USA, LLCFDA reg. 1222315 | ANDOVER, MA, United States | Complaint file establishment |
| Straumann Villeret SAFDA reg. 9614404 | VILLERET Bern, Switzerland | Manufacturer |
| Straumann Villeret SAFDA reg. 3007218081 | Corgemont Bern, Switzerland | Manufacturer |
Other names on FDA records
Anthogyr · ClearCorrect · Dental Wings Inc · JJGC Indústria E Comércio de Materiais Dentários S.A. · Medentika GMBH · Straumann Manufacturing, Inc. · Straumann Usa · Straumann Villeret SA · Biora AB · Etkon GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005052). 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.