Prosthetic devices · 21 CFR 872 Subpart D

Endosseous Dental Implant Abutment

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

FDA codeNHAClass221 CFR872.3630Pathway510(k)ImplantCategoryImplant abutments
Companies listing it
304267 makers
Brands and models
11,127
510(k) clearances
716195 in five years
FDA name
Abutment, Implant, Dental, Endosseous
1993: 31996: 21997: 31998: 12002: 52003: 62004: 132005: 152006: 312007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026: 2319801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NHA

304 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerAbutment components · CARES Abutment · CARES TAN Abutment · CARES® Advanced Bar · +1762122026
Dentsply Sirona, Inc.United StatesMakerAnkylos Cercon Balance · Ankylos Temporary Abutment Balance · Anti rotation cementing cap for connect abutment · Atlantis Abutment in Zirconia for 3i Certain MicroMini Implants · +181482026
Prismatik Dentalcraft, Inc.United StatesMakerBruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A1 · BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A2 · BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A3 · BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A3.5 · +1,382562026
Terrats Medical, S.L.SpainMakerArgen · DESS Dental Smart Solutions · DIRECTarch · INTEGRATED DENTAL SYSTEMS · +2232026
Dentis Co., Ltd.South KoreaMakerDentis Dental Implant System · Dentis i-Clean System · Dentis I-FIX Abutment · Dentis s-Clean Abutment Mini · +16372026
ARUM DENTISTRY Co., LtdSouth KoreaMakerAbutment Screw · Angled Abutment · Angled Abutment Mini · Cemented Abutment · +31172025
Megagen Implant Co., Ltd.South KoreaMakerAbutment Screw · Advanced Intermezzo System · AnyOne External Implant System · AnyOne Internal Implant System · +23302026
Nobel Biocare Services AGSwitzerlandMakerAbutment Blank · Abutment Screw NobelReplace · Angulated Screw Channel (ASC) Abutment · Attachment System · +102942026
Osstem Implant Co., Ltd.South KoreaMakerEK Dental Implants and Abutments · EK Multi Angled 30 Degree Abutment · ET Abutment System · ET Angled Abutments · +51682026
Elos Medtech Pinol A/SDenmarkMakerAbutment Blank · Abutment Screw · Abutment Screw NP · Access Abutment · +32142026
Izenimplant Co., Ltd.South KoreaMakerTi Link Abutment · ZENEX FreeMilling & CCM Cast Abutment · ZENEX Implant System · ZENEX Implant System_Narrow · +182026
GC America Inc.United StatesMakerGC AADVA ABUTMENT · GC Aadva Abutments Zirconium - BO, AC, BH, SV · GC Aadva Blend · GC AADVA BO AC ABUTMENTS · +21372026
Hiossen Inc.United StatesMakerEK Dental Implants and Abutments · EK Digital Abutments · EK Multi Angled 30 Degree Abutment · ET Abutment System · +28262026
Zest Anchors, LLCUnited StatesMakerR-Tx Abutments262026
Cowellmedi Co., Ltd.South KoreaMakerINNO SLA Mini Plus® Implant System · INNO SLA Sub Narrow Implant System · INNO SLA Sub Ti-base System · INNO SLA Submerged Implant System · +2142025
Ossvis Co., Ltd.South KoreaMakerLL Implant System · LL Mini Onebody Implant · LL Temporary Cap · LW Abutment Screw · +2972024
Southern Implants, Inc.South AfricaMakerAngulated Screw Channel Solution Abutments & SI-BASE Abutments · DC Implants and Accessories · Deep Conical Implants and Accessories · External hex anatomical abutments · +36222024
Talladium Espana, SLSpainMakerDynamic Abutment Solutions92026
Implant Protesis Dental 2004, S.L.SpainMakerAngled Multi-unit Screw M1.4 · Angled Multi-unit Screw M1.6 · Angled Multi-unit Screw M1.8 · Angled Multi-unit Screw M2 · +75162026
Ivoclar Vivadent, AGUnited StatesMakerAbutment Solutions for CEREC/InLab Starter Kit · IPS e.max CAD Abutment Solutions · IPS e.max CAD Abutment Solutions- extra systems · IPS e.max CAD CER/inLab LT · +4942026
BioHorizons Implant Systems, Inc.United StatesMakerBioHorizons Abutments for Zimmer · BioHorizons CAD/CAM Abutments · BioHorizons Laser-Lok 3 Implant System · BioHorizons Plastic Temporary Abutments · +16412026
Kuraray Noritake Dental, Inc.JapanMakerKATANA Zirconia ONE For IMPLANT322025
TruAbutment Inc.United StatesMakerTruAbutment DS · TruAbutment DS, TruBase172025
B.t.i. BiotechnologySpainMakerINPESPA1142024
Chengdu Besmile Medical Technology Co., Ltd.ChinaMakerBIORES Dental Implant System · Customized Abutment and Screw52026
Dental Direkt GmbHGermanyMakerDD Prefab · DD Ti-Base 2CUT · DD Ti-Base 2CUT noLock92024
Noris Medical Ltd.IsraelMaker—82025
Paltop Advanced Dental Solutions Inc.United StatesMakerAdvanced + Dental Implant System · Advanced + Dia 3.25mm Dental Implant System · Advanced + NP Dental System · Advanced Dia 3.25mm Dental Implant System · +3672025
Paragon Implant Mfg., LLCUnited StatesMakerGEN5 Implants and Prosthetics · GEN5+ Implants and Prosthetics · NizLoc · NizPlant · +142026
S.i.n. - Sistema de Implante Nacional S.A.BrazilMakerS.I.N. Dental Implant System · Sistema de Implante Nacional (S. I. N.) Dental Implant System42025
Implant DirectUnited StatesMakerCustom Legacy and Custom InterActive Titanium Abutments · InterActive SMARTBase Abutments · InterActive/SwishPlus2 Implant System · K060063 · +11242023
Young Innovations IncUnited StatesMakerImplant Prosthetic Components · Preat · Preat Abutments · PreatLoc232025
Blue Sky Bio, LLCUnited StatesMakerBlue Sky Bio · Blue Sky Bio CAD-CAM Abutments · Blue Sky Bio Dental Implant System - Bio / Conus · Blue Sky Bio Dental Implant System - Double Hex 3 Platform · +3202024
Park Dental Research CorpUnited StatesMakerStarVent Internal Hex Screw Implant · StarVent Internal Hex Screw Implant Abutments82026
Shinhung Mst Co., Ltd.South KoreaMakerMagDen Implant System · SI · SM · ST72023
Keystone Dental Inc.United StatesMakerGenesis ACTIVE · Genesis Dental Implant System · Genesis Implant System · MAX-TL Dental Implant System · +1072024
Jdentalcare SrlItalyMakerAbutment JDEvolution S · Abutment JDIcon · Abutment JDIcon Ultra S · Anatomic Abutment Angulated 15 H 1.5 JDEvolution Plus · +24652025
Imagine Milling Technologies, LLCUnited StatesMakerALLONUS Tech Prosthetics · Customized Abutment · DESS Dental Smart Solutions · Geo Abutment · +342026
Open ImplantsUnited StatesMakerNeodent Grand Morse · Sherlock Abutment42025
ADIN DENTAL IMPLANT SYSTEMS LtdIsraelMakerAdin Dental Implants System · ADIN UNIFIT DENTAL IMPLANT SYSTEM · Anatomic Abutments · C-Type Ti Base · +7532026
Zentek Medical LLCUnited StatesMakerBonafix · Bonafix 2 Plus · Bonafix Ti Base · Dentlot · +232025
Simda Co., Ltd.South KoreaMakerLab Analog · Scan Body · SIMDA Abutment32025
Neobiotech Co., Ltd.South KoreaMakerCMI implant EB System · CMI IMPLANT IS SYSTEM · IS Multi Unit Abutment System · IS-III active System · +4172024
InnoBioSurg Co.,LtdSouth KoreaMakerAMII Implant Closing Screw · AMII Implant Healing Cap · AMII Implant Healing Cap Screw · AMII Implant System · +4152022
Hager& Meisinger GmbHGermanyMakerAngled Abutments OKTAGON Bone Level · Dental Implant Abutment OKTAGON · myplant two Abutment · myplant two Ball Anchor · +12142025
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.GermanyMakerVITA ENAMIC® Implant Solutions (IS)82026
Biotem Co., Ltd.South KoreaMakerAR_N Type Implant System · BR SLA Type Implant System · BR Type Implant System · IR SLA Type Implant System · +262023
SIC invent AGSwitzerlandMaker—52026
WARANTEC Co., Ltd.South KoreaMakerFIU36085 · FIU36100 · FIU36115 · FIU36130 · +41842023
TRI Dental Implants Int. AGSwitzerlandMakerTRI Dental Implant System · TRI-matrix Implant Line32025
SNUCONE Co., LTD.South KoreaMakerSNUCONE BONE LEVEL IMPLANT SYSTEM · SNUCONE TISSUE LEVEL IMPLANT SYSTEM22023
Ditron Dental LtdIsraelMakerAbutment multi post screw, Multi-unit abutment screw, Multi-unit prosthetic screw. · Abutment, Implant, Dental Endosseous · Accelx cover screws · Accelx dental implants · +2722024
ZEROS Co., Ltd.South KoreaMakerIOS Abutment · STERI-OSS Implant System · ZEROS Dental Implant System22026
Oneday Biotech Co., Ltd.South KoreaMakerOneday Implant Abutment · Oneday Mini Implant System22024
Modern Dental Laboratory Co., Ltd.ChinaMakerDESS Dental Smart Solutions22024
Smart Denture Conversions, LLCUnited StatesMakerProsthetic Screw, Paltop (IHex)22026
Unidental Co., Ltd.South KoreaMakerUNIdental Symphony Implant System22026
Infinitum Eta Ltd.IsraelMaker—22025
Dentium USAUnited StatesMakerAAB154515H · AAB154515HE · AAB154515HL · AAB154515HT · +849232022
DIO CorporationSouth KoreaMakerBar holder Abutment · Bar holder Cap Abutment · DIO CAD/CAM Abutment · DIO Customized Abutment · +127142023
KJ Meditech Co., Ltd.South KoreaMakerConical Plus Implant System · HERO I DENTAL IMPLANT SYSTEM · HERO II DENTAL IMPLANT SYSTEM · HexaPLUS S OneDrill Implant System · +12132022
The Argen CorporationUnited StatesMakerArgenIS · ArgenIS Angled Screw Channel (ASC) Titanium Blanks · ArgenIS Angled Screw Channel (ASC) Titanium Screws · ArgenIS Titanium Abutments112024
Neoss ABSwedenMakerNeoss Individual Prosthetics · 1- 6mm Locator Abutment for Neoss 4.1mmD Implant102022
Soadco, S.L.AndorraMakerKLOCKNER ABUTMENTS · Klockner Dental Implant Abutments · Klockner Dental Implant Abutments (II) · Klockner Vega Dental Implant System · +192023
A.B. Dental Devices , Ltd.IsraelMakerA.B. DENTAL DEVICES Dental Implants System · AB Dental Devices Dental Implants · AB LOC H1mm Conical Platform · AB LOC H2mm Conical Platform · +20142026
Alpha-Bio TecIsraelMakerAbutment Screw - CS · Adhesive Coping for D3.5 MU · Angled Ti abutment 10 ° 1.5 CHC · Angled Ti abutment 10 ° 1.5 CS · +14242026
Alpha Dent Implants GmbHGermanyMakerdental Implant " Implant Classic_" · DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABP · dental implants "Implant Active Bio_" · HCAEK Healing Cap for Aesthetic Abutment Konus · +7932024
BIO CONCEPT Co., LtdChinaMakerBLT Dental Implant System · BV Dental Implant System · Dental Implant System32022
Surgikor, LLCUnited StatesMakerAbutment Screw · Anatomic Straight Abutment · Anti-Rotation Abutment · Ball Attachment Abutment · +3022024
Uniqa Dental, Ltd.IsraelMakerBall attachment abutment · Conical Implant, Internal Hex, Pure & Porous, P&P · Conical Implant, Internal Hex, SBA · Conical Implant, Pure & Porous, P&P · +5122026
Sewon Medix, Inc.South KoreaMakerBIOTHREAD BT3 Implant System · IH Implant System22023
DSI Dental Solutions LtdIsraelMakerDSI Dental Implant System22025
Biotech DentalFranceMakerKontact Dental Implant System · KontactTM Dental Implant System22022
Avinent Implant System S.L.U.SpainMakerAVINENT IMPLANT SYSTEM · AVINENT IMPLANT SYSTEM S.L.22026
Osseofuse International Inc.United StatesMakerHexaPLUS S · HexaPLUS S OneDrill Implant System22025
Eclectic Co., Ltd.South KoreaMakerPreXolid Abutment Screw 2.10mm Hex1.20mm ASMR · PreXolid Abutment Screw 2.10mm Hex1.23mm ASPM · PreXolid Abutment Screw 2.10mm Hex1.74mm ASSR · PreXolid Abutment Screw 2.20mm Hex1.74mm ASSM · +36312024
Mozograu S.A.SpainMakerTicare Dental Implant Systems12024
ZimVie US Corp LLCUnited StatesMakerAbutment Post · BellaTek Abutment · BellaTek Certain TiN Abutment · BellaTek Certain Titanium Abutment · +14712026
Cybermed Inc.South KoreaMakerCORE1 Implant System · REBORN ImplantSystem12022
DIMPLO Ltd.South KoreaMakerDIMPLO Implant System12025
Bioline Dental Implant Systems LtdIsraelMakerBioline Dental Implant System12025
Inosys, Inc.United StatesMakerAbutment Screw · Cemented Abutment (HEX) · Cemented Abutment (NON-HEX) · Closing Screw · +712026
Alien Milling TechnologiesUnited StatesMakerBlue Sky Bio Custom Titanium Abutment · DESS Custom Titanium Abutments · DESS Dental Smart Solution · DESS Dental Smart Solutions · +312024
ALLONUS Tech Co., Ltd.South KoreaMakerALLONUS Tech Prosthetics12024
GeoMedi Co., Ltd.South KoreaMakerGeo Abutment · Geo CMFit Abutment · Geo Multibase Abutment · Geo Screw · +112025
Biotech DentalUnited StatesMakerKontact · Reflect12024
Creodent Hudson ValleyUnited StatesMakerSolidex12026
Roott LLCUnited StatesMakerTRATE DENTAL IMPLANT SYSTEM · TRATE DENTAL IMPLANT SYSTEM - ROOT IMPLANT AND ABUTMENT12022
Surcam Medical Devices and Developments LtdIsraelMakerSurcam Dental Implant System12025
d.a.n.d metal industries north LTDIsraelMakerDAND Dental Implant System12025
DenQ Co., Ltd.South KoreaMakerDenQ Sub SLA Implant System12024
IDIS Co. Ltd.South KoreaMakerS-Plant Dental Implant System12023
Quickdent Devices Private LimitedIndiaMakerQuickdent Dental Implant System12024
RDJ TOV Implant LtdIsraelMakerTOV Dental Implant System12024
REX Implants, IncUnited StatesMakerPiezoImplant System12022
EuroteknikaFranceMakeriPhysio System Profile Designer, iPhysio System Temporary Abutments12025
highness Co.,Ltd.South KoreaMakerHIGHNESS IMPLANT SYSTEM12024
OrangeCAD Med GmbHGermanyMakerOrangeCAD Med Abutments12025
OsteoCentric Technologies IncUnited StatesMakerOsteoCentric Dental Implant System12023
Z7 LLCUnited StatesMakerZiNova Implants12023
Thommen Medical AGSwitzerlandMakerMilling Abutment for CAD/CAM · SPI ART · SPI ART Abutments · SPI Contact PF 4 · +11262017
SterngoldUnited StatesMakerMOR 3mm and PUR 3.2mm Implant Systems, Mor 2.1x18mm and MOR 2.4x18mm Implants · MOR Dental Implant System · ORA Implant Abutments · Sern IC Dental Implant System · +5242017
Bicon, LLCUnited StatesMakerMAX 2.5 Implant System182015
CAMLOG Biotechnologies GmbHSwitzerlandMaker—142020
Biodenta Swiss AGSwitzerlandMakerBiodenta Customized Abutment - Hybrid · Biodenta Customized Abutment - Titanium · Biodenta Dental Implant System - Abutments · Biodenta Dental Implant System - Bone Level D 3 to 6 mm · +1112015
Z-Systems AGSwitzerlandMakerZ5-BL · Z5-TL · Z5c82020
SWEDEN & MARTINA S.p.A.ItalyMakerABUTMENT PLAIN SCREW M2 · ABUTMENT PLAIN SCREWS M2 · ABUTMENT SCREW · ABUTMENT SCREW M1.8 · +31562019
Panthera Dental Inc.CanadaMakerDental Milled Bars Panthera · Milled Bars Panthera Dental · Panthera Dental Milled Bar52020
Rhein'83 SrlItalyMakerKEF44SMD331 ALL ON FOUR EASY FIX SEVEN ø3,3 h.1 · KEF46NAC354 ALL ON FOUR EASY FIX YOUSE V 3,3/3,75h.4 · KEF46OCT33 ALL ON FOUR EASY FIX synOCTA O/I h.3,3 · KEF46PRK333 ALL ON FOUR EASY FIX PRE.KOHNO H. 3 · +32642018
Cortex Dental Implants Industries Ltd.IsraelMakerBCDL-0833 BCDL-0838 BCDL-0842 BCDL-1033 BCDL-1038 BCDL-1042 MPN-S010 MPW-S010 MPR-0055 MPR-0070 MPW-S006A · BCDL-1133 BCDL-1138 BCDL-1142 BCDL-1333 BCDL-1338 BCDL-1342 BCDL-1633 BCDL-1638 BCDL-1642 · BCO-CC309 BCO-CC409 BCO-CC509 BCO-CC218 BCO-CC318 BCO-CC418 BCO-CC518 BCO-CC230 BCO-CC330 BCO-CC430 · BCO-CC530 PCO-CC209 PCO-CC309 PCO-CC409 PCO-CC509 PCO-CC218 PCO-CC318 PCO-CC418 PCO-CC518 PCO-CC230 · +15942019
Medimecca Co., Ltd.South KoreaMakerBiothread Dental Implant System · Biothread Dental Implant Systems · CHAORUM Implant System · DISOAR Implant System · +542020
CSM ImplantSouth KoreaMakerCSM Submerged3-L Implant System · implant1 · implant242018
Oco BiomedicalUnited StatesMakerTSI / ERI; ENGAGE / ENGAGE PLUS42013
Titan Implants, Inc.United StatesMakerTitan Implants42005
KAT Implants, LLCUnited StatesMakerAbutment SR 2.7 · Abutment SR 20º · Abutment SR 3.5 · Angle Abutment 4.2 10º · +9332012
OT medical GmbHGermanyMakerCreativeLine · NaturalLine · NaturalLine Abutment · OT-F² Implants · +532016
United Dental Resources CorporationUnited StatesMakerAbutment, Implant, Dental, Endosseous - Biodenta Customized Abutment - Hybrid · Abutment, Implant, Dental, Endosseous - Biodenta Customized Abutment - Titanium · Abutment, Implant, Dental, Endosseous - Preat Abutments32021
RODO Medical, Inc.United StatesMakerRodo Abutment System · Rodo Smileloc · Smilekey32020
TAV MedicalIsraelMakerTAV Dental Implant System32019
S.G.S. International LtdHungaryMakerAbutments Plastic for Casting with Titanium Base & Hex · Adaptor · Anatomic Angular Abutment · Anatomic Angular Abutment for 7PN · +7922019
Ritter Implants GmbH and Co. KGUnited StatesMakerRitter Dental Implant System · Ritter Dentals · Ritter Implant system – small sizes22019
Suncoast Dental Corp.United StatesMakerSuncoast Dental, Inc. Dba Tatum Surgical21981
Surgident Co., Ltd.South KoreaMakerSD Abutment22019
Cendres+Metaux SASwitzerlandMakerCM LOC Abutment · CM LOC Abutment Straumann® RN 4.8 GH1 · CM LOC Abutment Straumann® RN 4.8 GH2 · CM LOC Abutment Straumann® RN 4.8 GH3 · +722020
GC OrthodonticsUnited StatesMaker—22015
Hung Chun Bio-S Co., Ltd.TaiwanMakerTIONE TS Dental Implant System22018
Alliance Global Technology Co., Ltd.TaiwanMakerABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS · IMPLANT, ENDOSSEOUS, ROOT-FORM22016
Zuga Medical, Inc.United StatesMakerZuga · Zuga Medical Dental Implant System22018
Implacil DE Bortoli Material Odontologico LtdaBrazilMakerAbutment, Implant, Dental, Endosseous - Implacil Implant System · Implant, Endosseous, Root-Form - Implacil Implant System22021
American Dental Implant CorporationUnited StatesMakerADI Abutment22008
Sudimplant SAFranceMakerTBR Zirconnect22007
Dental Evolutions, Inc.United StatesMakerImplanova22021
BEGO Implant Systems GmbH & Co. KGGermanyMaker—22021
SDS Swiss Dental Solutions AGSwitzerlandMaker—22020
TAG Medical products corporation LTDUnited StatesMakerAnatomic Abutment H1mm L4mm · Anatomic Abutment H1mm L6mm · Anatomic Abutment H1mm L8mm · Anatomic Abutment H2mm L4mm · +39712015
Hi-Tec ImplantsIsraelMakerAAT · AAT-L · ACA · ACA-0 · +38111994
Abracadabra Implants Ltd.IsraelMakerBO0833 - Bolero 3.3 mm in diameter · BO0837 - Bolero 3.75 mm in diameter · BO0842 - Bolero 4.2 mm in diameter · BO0850 - Bolero 5 mm in diameter · +7912021
DENTIN Implants Technologies Ltd.IsraelMakerAbutment System · Aesthetic Minor Unit · Anatomic Angulated Titanium Abutment · Anatomic Titanium Abutment · +2212012
Nova ImplantsIsraelMakerANG Anatomic Angulated Abutment · ANTAnatomic Angulated Curve · ASM Angulated Abutment · BAT Ball Attachment · +1612015
Iq Implants , Ltd.IsraelMakerAesthetic Abutments · Anatomic Angled Abutments 15 Degrees · Anatomic Angled Abutments 25 Degrees · Angled Abutments 15 Degrees · +1512013
Gebr. Brasseler GmbH & Co. KGGermanyMaker—12007
T Strong, Inc.South KoreaMakerU fit Dental Implant System12014
Ziacom Medical, S.L.SpainMakerCORVEN · Ziacom Zinic · Ziacom Zinic MT · Ziacom Zinic MTX · +112019
BiosealUnited StatesMakerImplanova11988
Dental Crafters Inc.United StatesMakerBiodenta Customized Abutments - Titanium · DESS Dental Smart Solutions · DESS Dental Smart Solutions - Keystone · Genesis ACTIVE Abutments · +112009
Medical Systems and Devices International Ltd.IsraelMakerAlef, Kaf, Taf MSDI Dental Implants System12020
alfa gate - mazen ltd.IsraelMakerAlfa Gate12019
F&B Technology Co., Ltd.South KoreaMakerFit & Brilliant Dental Implant System12020
GP Implants LtdIsraelMakerGP Implant System12017
Jiangsu Trausim Medical Instrument Co.,Ltd.ChinaMakerTrausim Dental Implant System12014
Buckeye Medical Technologies LLCUnited StatesMakerAnatotempSC12017
8dent Inc.South KoreaMakerADD-ON Implant System - ADAAM4010 · ADD-ON Implant System - ADAAM4020 · ADD-ON Implant System - ADAAM4030 · ADD-ON Implant System - ADAAM4040 · +1,652——
BHI Implant l Ltd.IsraelMakerABA1801 · ABA1802 · ABA1803 · ABA3001 · +452——
Noga Medical Products Ltd.IsraelMakerAxis Implant ø3.30 L10mm · Axis Implant ø3.30 L11.50mm · Axis Implant ø3.30 L13mm · Axis Implant ø3.30 L16mm · +206——
Precision One MedicalUnited StatesMakerAbutment Screw, Multi-unit Abutment · BioHorizons CAD/CAM Abutments · BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK · BioHorizons Tapered Internal Implant · +137——
Intai Technology Corp. Implants Business UnitTaiwanMakerBIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENT · PREFORMANCE POSTS AND TEMPORARY CYLINDERS · ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM · TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620——
TruAbutment Korea Co LtdSouth KoreaMakerAOT & T-L Abutment · TruAbutment DS · TruAbutment DS, TruBase · TruBase · +3——
D.S.P. Industrial EIRELI EPPBrazilMakerHE ANATOMICAL ABUTMENT · HE ANATOMICAL HEALING ABUTMENT · HE BIOFIT DENTAL IMPLANT · HE COCR BASE UCLA · +30——
PointImplant Co LtdSouth KoreaMakerAbutment Screw · Angled Abutment · Cemented Abutment · Cover Screw · +7——
ACH Medical Co., Ltd.South KoreaMakerAIMGEN · Biogenesis Implant System - Aticon · Biogenesis Implant System - Kisses · IB · +12——
Schweizer Feinwerktechnik GmbHGermanyMakerPREFIT10 3IC 3.4 · PREFIT10 3IC 4.1 · PREFIT10 3IC 5 · PREFIT10 3IC 6 · +61——
BBF Sterilisationsservice GmbHGermanyMakerCAMLOG Healing caps · CAMLOG Healing caps PS · CAMLOG SCREW-LINE IMPLANTS · CONELOG Healing caps · +11——
Micro Precision Swiss, LLCUnited StatesMakerAbutment Screw Retrieval Instrument · ASC Abutment · EVOS SMALL FRAGMENT PLATING SYSTEM · Implant Driver NobelActive · +3——
Digital Age Dental Laboratories, Ltd.United StatesMakerBiodenta Customized Abutment - Titanium · Biodenta Customized Abutment-Hybrid · BioHorizons Tapered Internal Implant System (includes 3-in-1 abutments) · BioHorizons Tapered Pro Conical Implant System (Conical Esthetic Abutments, 0°, 2 mm GH, Narrow platform) · +19——
Elos Medtech ABSwedenMaker———
LX Precision Shanghai Co. Ltd.ChinaMakerBIOMET 3i Dental Abutments——
Laboratorios Dentales de Zona Franca, S.A.Costa RicaMakerCustom Abutment - 3i Certain · Custom Abutment - Ankylos · Custom Abutment - Astra · Custom Abutment - Astra EV · +12——
Accumedix, Inc.United StatesMakerBio Conus, Bio Max, and Bio Quattro Implant Systems · Blue Sky Bio CAD-CAM Abutments · Blue Sky Bio Dental Implant · Blue Sky Bio Pterygoid Implants and Abutments · +2——
Vulcan Custom DentalUnited StatesMakerAltatec TiBase CAD/CAM Hybrid Bridge · BioHorizons CAD/CAM Bars · BioHorizons Tapered Pro Conical Dental Implant Abutments · Camlog TiBase CAD/CAM Hybrid · +10——
LX Precision Portugal, Unipessoal, LdaPortugalMakerHEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 · ZIMMER CONTOUR PROVISIONAL COPING · ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) · Zimmer Dental Inc. · +1——
Dentauspex CorporationTaiwanMakerBiodenta Customized Abutment - Hybrid · Biodenta Customized Abutment - Titanium · BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS · BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT · +1——
Superior Machined Products, Inc.United StatesMakerBlue Sky Bio · Intralock——
Paragon Implant Company, LLCUnited StatesMakerGEN5 Implants and Prosthetics · GEN5+ Implants and Prosthetics · NizLoc · NizPlant · +1——
RODO Digital Prosthetics LLCUnited StatesMakerAbutment · DESS Dental Smart Solutions · KEYSTONE ABUTMENT SYSTEM · KEYSTONE-Genesis Implant System · +7——
Frueh Verpackungstechnik AGSwitzerlandMakerCIM 3.3 mm ND · SDS 1.2 Dental Implant——
Hexa Ceram Co., Ltd.ThailandMakerCustomized Abutment · NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN; NNC Variobase Abutment, with screw, D 55mm, H 4mm——
Millstone Medical Outsourcing LLCUnited StatesMakerPrimaConnex Dental Implant System · STAGE-1 Dental Implant System——
Burbank Dental LabUnited StatesMakerAB Dental Abutment · BDL AB · BDL Keystone · Keystone Abutment · +3——
Leixir Resources Private LimitedIndiaMakerAbutment, Implant, Dental, Endosseous- Biodenta customized abutment hybrid · Abutment, Implant, Dental, Endosseous- Biodenta Customized Abutment- Titanium——
New Image Dental Laboratory, Inc.United StatesMakerAbutment, implant, dental, endosseous, Blue Sky Bio CAD-CAM Abutments · Abutment, implant, dental, endosseous, DESS Dental Smart Solutions · Abutment, Implant, Dental, Endosseous, HIOSSEN Pre-milled Abutments · Abutment, implant, dental, endosseous, Straumann CARES M-Series CAD/CAM System · +3——
Oral Arts Laboratory, Inc.United StatesMakerAbutment, Implant, Dental, Endosseous-Keystone Abutments · Abutment, Implant, Dental, Endosseous-Preat Abutments · Abutment, Implant, Dental, Endosseous, Biodenta Customize Abutment-Hybrid · Abutment, Implant, Dental. Endosseous,-Biodenta Customized Abutment-Titanium——
Pan-Am Dental, Inc.United StatesMakerAbutment, Implant, Dental, Endosseous - Biodenta · Preat Abutments——
R2 Digital Milling Technologies IncUnited StatesMakerANYONETM INTERNAL IMPLANT SYSTEM · ANYRIDGE INTERNAL IMPLANT SYSTEM · ARi ExCon Implant System · MegaGen Dental Implant Abutment · +2——
Implant Logistics / AMS MicromedicalUnited StatesMakerImplant Logistics, Inc · Implant Logistics, Inc; Implant-One · Implant Logistics, Inc; Implant-One Multi-Unit Abutment · Implant-One——
SMD Dental LaboratorySouth KoreaMakerCustom Abutment · Custom Abutments——
Theia Holding SASwitzerlandMaker———
UFP Technologies, Inc.United StatesMakerMULTIPLE DENTAL IMPLANT SYSTEMS——
GMI Dental Implantology, S.L.SpainMakerGMI Frontier dental implant system——
KTJ Medical Technology Co.,Ltd.ChinaMakerDess Dental Smart Solution——
Proto3000 Inc.CanadaMakerDental Direkt GmbH——
Shenzhen Jiahong Dental Technology Co., LtdChinaMakerNHA——
Preferred Oral Design LimitadaCosta RicaMakerAbutment, implant, dental, endosseous · NHA / Abutment, implant, dental, endosseous · Straumann CARES M-Series CAD/CAM System——
puracon GmbHGermanyMakerendosseous implant, root form · IMPLANT, ENDOSSEOUS, ROOT-FORM——
ARCH Medical Solutions - Escondido LLCUnited StatesMakerAbutment, implant, dental, endosseous——
Army Dental LaboratoryUnited StatesMakerabutment, implant, dental, endosseous · biodenta customized abutment - hybrid · biodenta customized abutment - titanium · coritec · +1——
Baechler Feintech AGSwitzerlandMakerMedentika Abutment System——
CeramTec Schweiz GmbHSwitzerlandMakerZeramex Dental Implant System——
EXCELDENT Dental Technology Development Co., Ltd.ChinaMakerDess Implant——
GCDL, LLCUnited StatesMakerPreat Abutments——
Josef Ganter Feinmechanik GmbHGermanyMaker———
Reliable Arts Dental Laboratory LLCUnited StatesMakerAbutment, Implant, Dental, Endoseous - Dess Titanium Custom Abutment · Abutment, Implant, Dental, Endosseous - Abutment, Implant, Dental, Endosseous, Biodenta Customize Abutment-Hybrid · Abutment, Implant, Dental, Endosseous - Abutment, Implant, Dental. Endosseous,-Biodenta Customized Abutment-Titanium · Abutment, Implant, Dental, Endosseous - Dess Titanium Custom Abutment · +1——
Whitecap Dental Lab and Milling, LLCUnited StatesMakerDIO CAD/CAM Abutment · UF(II) Hybrid link abutment · UF(II) Patient-specific abutment——
Argon Dental Vertriebs Gmbh & Co. KGGermanyMakerK3Pro Konus Additional Abutments and Implants · K3Pro Konus Dental Implant System——
Barksdale DentalUnited StatesMakerAbutment, Implant, Dental, Endosseous - Biodenta Customized Abutment - Hybrid · Abutment, Implant, Dental, Endosseous - Biodenta Customized Abutment - Titanium · Preat Abutments——
Daekwang IdmSouth KoreaMakerAbutment, implant, dental, endosseous · IMPLANT, ENDOSSEOUS, ROOT-FORMAbutment, implant, dental, endosseous——
DMITechnology LLCUnited StatesMakerDMI Dental Implant System——
Dti Implant SystemsTürkiyeMakerDTI——
Evidence Implant Inc.South KoreaMakerInternal Hex Implant System——
IPB IncUnited StatesMaker———
Kelsey Dental LLCUnited StatesMakerSTRAUMANN DENTAL IMPLANT SYSTEM——
Precera Medical IncUnited StatesMakerZimmer Contour Restorative System——
Topway Dental Laboratory Co., LtdChinaMakerEndosseous Dental Implant Abutment——
ARDS IndustriesIsraelMakerARDS Dental Implant——
Bayou State Crown & Bridge LabUnited StatesMakerAbutment,implant,dental,endosseous-biodenta customized abutment-titanium · Preat Abutments——
Cornerstone Biocomp Enterprises Inc.United StatesMakerAbutment, implant, dental, endosseous - Keystone Abutment · Abutment, implant, dental, endosseous - Neoss Abutment · Abutment, implant, dental, endosseous - Preat Abutment——
Gunter Medical GmbHGermanyMakerZuga——
JamesB Dental StudioUnited StatesMakerSolidex——
Osteon MedicalAustraliaMakerDESS Dental Smart Solutions · Osteon Precision Milled Suprastructure——
Zima International, Inc.United StatesMakerDESS Dental Smart Solutions · Medentika CAD/CAM TiBases——
Aeton MedicalUnited StatesMakerST Abutment Systems——
CBD Dental Lab, Inc.ChinaMakerDynamic Abutment Solutions——
DOT America, Inc.United StatesMaker———
Elegant Direct Corp.United StatesMakerDURANEXT——
Express Dental LaboratoryUnited StatesMakerAbutment, Implant, Dental, Endosseous-Preat Abutments · Abutment, Implant. Dental, Endosseous - Preat Abutments——
Knight Dental GroupUnited StatesMakerAbutment, implant, dental, endosseous · Preat Abutments——
Louisiana Dental Implant LabUnited StatesMakerabutment, implant, dental, endosseous——
Maestro LogisticsUnited StatesMakerDental Implant System——
New Perfect Dental LabChinaMakerDess Implant——
Primo Medical Group, IncUnited StatesMaker———
Roott UABLithuaniaMakerTRATE Dental Implant System——
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi ve Ticaret AnonTürkiyeMakerNucleoss——
Selenium Medical S.A.S.FranceMakerKONTACT DENTAL IMPLANT SYSTEM——
Shimmer Computerized Dental Technology Co.,LTDChinaMakerDess Implant——
SynorossUnited StatesMakerOsseOne Dental Implant System——
Zhuhai Crystal Dental Technology Co.,LtdChinaMakerZHUHAI CRYSTAL DENTAL TECHNOLOGY CO. ,LTD——
3POINT Dental Inc.South KoreaMakerMIST IC——
COHO Advanced Materials Tech. Co., Ltd.TaiwanMaker———
DDS Caribbean CorpUnited StatesMakerDD Solid Connect® CAD/CAM Abutments——
DTS Digital Dental LabChinaMakerDess Dental Smart Solution——
Excel Medical Products, Inc.United StatesMakerAnatotemp——
FMZ GmbHGermanyMakerDRA——
Georgia High Tech Dental Lab IncUnited StatesMakerAbutment, implant, dental, endosseous——
LASAK s.r.o.CzechiaMakerGenTek——
Quality Tech Services, LLCUnited StatesMakerInternal/Single-stage Abutment Screw——
Willo ABSwedenMakerHealing abutments, dental——
Arch Medical & Aerospace-Minneapolis, LLCUnited StatesMaker———
Autocam MedicalUnited StatesMaker———
Biostar Laboratorios SLUSpainMaker———
Blue Elephant IncUnited StatesMaker———
Ceramaret SASwitzerlandMaker———
CeramTec GmbHGermanyMaker———
CPM Precision GmbHGermanyMaker———
Diener AG Precision MachiningSwitzerlandMaker———
Eurofins inpac Medizintechnik GmbHGermanyMaker———
Faulhaber Pinzetten KGGermanyMaker———
Himed, LLC.United StatesMaker———
Hipp Medical AGGermanyMaker———
InfinetaMed AGSwitzerlandMaker———
Khoury Dent Ltd Via Kasko K.N LtdIsraelMaker———
Klingel medical metal GmbHGermanyMaker———
Microcision LLCUnited StatesMaker———
Part Precision Sweden ABSwedenMaker———
Phen'X TechnologiesFranceMaker———
Rickli Micromecanique SASwitzerlandMaker———
Samaplast AGSwitzerlandMaker———
Steripac GmbHGermanyMaker———
Wesley Coe (Cambridge) Ltd.United KingdomMaker———
PaloDEx Group OyFinlandForeign exporterDTX Studio Lab92024
Manufacturera Dental ContinentalMexicoForeign exporterPaltop Dental Sterile Accessories · Paltop Dynamic C Dental Implant System · Paltop Narrow Implant, Paltop PCA Dental Implant system22001
National Dentex LLCUnited StatesContract manufacturerBiotenta Customized Abutment - Hybrid · Biotenta Customized Abutment - Titanium · DESS Ti Base Abutments · Preat Abutments12012
Sotera Health LLCUnited StatesContract manufacturerCERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT · CERTAIN® EP® HEALING ABUTMENT · CERTAIN® GINGHUE TM ANGLED POST · CERTAIN® GINGIHUE® ANGLED POST · +262——
Sweden & Martina INCUnited StatesListerCAST. NON REP. POST WITH CRCO · CAST. NON REP. POST WITH GOLD · CASTABLE REP. POST WITH CRCO · CASTABLE REP. POST WITH GOLD · +35——
Jersey Dental SuppliesUnited StatesRepacker / relabelerDSI Dental Implant System · 3 Dynamic TiBase——
Swann Morton LimitedUnited KingdomContract sterilizerAcess Abutments · Dental Implant System · Neoss Access Abutments · Neoss Implant System 3.25 · +2——
STERIS CorporationUnited StatesContract sterilizerAccumedix3772 (LS) - Blue Sky Bio · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Bio / Conus · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Double Hex 3 Platform · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Octagon Regular and Wide Short · +10——
Curitiba Esterilizacao De Materiais Medicos LTDABrazilContract sterilizerCR Abutment for Zirconia Implant System · DIRECT CONNECTION SCREW TO MULTI UNIT ABUTMENT Neodent Implant System · GM ATTACHMENT TIN FOR REMOVABLE PROSTHESIS Neodent Implant System · GM Narrow Implant System · +21——
IDOC Dental LabUnited StatesContract manufacturerAbutment, implant, dental, endosseous · DenQ Sub Multi-unit Abutment(Angled-1) DSMAR493017OS · DenQ Sub Multi-unit Abutment(Angled-1) DSMAR494017OS · DenQ Sub Multi-unit Abutment(Angled-1) DSMAR494030OS · +8——
Sor Van Radiation LtdIsraelContract sterilizerAccelx dental implants · APC (Conical Connection Advanced Precision Implant) · API - Advanced Precision Implant · Axis Implants · +13——
Aragogamma, S.L.SpainContract sterilizerHex-Lock Short Abutment · Plastic Temporary Abutment · Prepared Hex-Lock Abutment · Provisional Coping · +3——
Meta Dental Corp.United StatesRepacker / relabelerZirace——
anaxdent North AmericaUnited StatesListerCM Connect——
Epione BidcoFranceContract sterilizerAnthogyr AXIOM® BL X3 implants · Anthogyr Multi-Unit components for AXIOM® BL · axiom BL 2.8 · axiom BL reg——
Dental Plus USA, LLCUnited StatesRepacker / relabelerMulti-Unit Analog, Screw, Abutment——
Greenpia Technology Inc.South KoreaContract sterilizerJ2A Dental Implant System, J2C Dental Implant System · Osseofuse Dental Implant System——
BioAbutment Inc.United StatesListerALLONUS Tech Prosthetics——
Dentaline LLCUnited StatesListerBiodenta · dentaswiss——
Greiner Mediscan GmbHAustriaContract sterilizerPrama White Implant Systems · Premium Shelta Implant Systems——
F.M. Howell & Co.United StatesRepacker / relabelerBlueSkyBio——
KTJ Dental Lab Company LimitedHong Kong SAR ChinaPrivate-label distributorAbutment, Implant, Dental, Endosseous · Dess Dental Smart Solution——
LBN Medical ApSDenmarkForeign exporterL8-3 freesyle——
MEDEALIS GmbHGermanyForeign exporterDESS Dental Smart Solutions——
Acer Dental Lab Co LtdHong Kong SAR ChinaForeign exporterDess Implant——
Global Dental Transfer LtdIsraelRepacker / relabelerGlobal Dental Transfer Dental Implant System——
Wise Way (HK) Trading LimitedHong Kong SAR ChinaForeign exporterDynamic Abutment Solutions——
E-BEAM Services, Inc.United StatesContract sterilizerAnatotempSC——
LYNX Medical NJUnited StatesContract sterilizerQuadric Dental Implants——
AMG Dental LtdIsraelRepacker / relabeler———
BGS Beta-Gamma-Service GmbH & Co KGGermanyContract sterilizer———
Edental Lab Co., LtdChinaContract manufacturer———
Implant Attachments LLCUnited StatesRepacker / relabeler———
Mainline Medical Dental SupplyCanadaForeign exporter———
MHM Grupo Diamante, S.A. de C.V.MexicoForeign exporter———
NuVentus AGSwitzerlandForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
30 Sep 2026K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S
23 Sep 2026K262207Cemented Plus AbutmentUnidental Co., Ltd.
21 Sep 2026K260940BellaTek BarsZimVie US Corp LLC
6 Aug 2026K253999Universal 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 ScrewNobel Biocare Services AG
1 Jul 2026K261147Neodent Implant System - NeoConvert FitInstitut Straumann AG
27 Jun 2026K261122MIST ICImagine Milling Technologies, LLC
26 Jun 2026K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.
15 Jun 2026K253922Neodent Scannable Healing AbutmentInstitut Straumann AG
11 Jun 2026K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC
9 Jun 2026K260564DESS Dental Smart SolutionsTerrats Medical, S.L.
3 Jun 2026K252904SIC Abutments including CAD/CAM SolutionsSIC invent AG
20 May 2026K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S
14 May 2026K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen Inc.
7 May 2026K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG
16 Apr 2026K253804DESS Dental Smart SolutionsTerrats Medical, S.L.
9 Apr 2026K260555LOCATOR® Angled AbutmentZest Anchors, LLC
4 Mar 2026K251434Healing Abutment SystemOsstem Implant Co., Ltd.
10 Feb 2026K251515Solidex® Ti-Links and ScrewsCreodent Hudson Valley
29 Jan 2026K251427EK MULTI ANGLED 30 ABUTMENTHiossen Inc.
29 Jan 2026K243732Multi-Unit DAS SystemTalladium Espana, SL
22 Jan 2026K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AG
22 Jan 2026K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.
7 Jan 2026K252727Neodent InLab Validated WorkflowInstitut Straumann AG
23 Dec 2025K253341Custom Abutments ASInstitut Straumann AG
23 Dec 2025K253312OrangeCAD Med AbutmentsOrangeCAD Med GmbH
18 Dec 2025K252320SIMDA AbutmentsSimda Co., Ltd.
9 Dec 2025K252343Atlantis® Abutments in TitaniumDentsply Sirona, Inc.
26 Nov 2025K252248CEREC Tessera Abutment SystemDentsply Sirona, Inc.
21 Nov 2025K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona, Inc.
18 Nov 2025K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsPrismatik Dentalcraft, Inc.
31 Oct 2025K251547DESS Dental Smart SolutionsTerrats Medical, S.L.
23 Oct 2025K252384DESS® Dental Smart SolutionsTerrats Medical, S.L.
17 Oct 2025K252266S.I.N. Dental Implant SystemS.i.n. - Sistema de Implante Nacional S.A.
17 Oct 2025K250178Adin Customized AbutmentsADIN DENTAL IMPLANT SYSTEMS Ltd
16 Oct 2025K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S
15 Oct 2025K252944LOCATOR® Angled AbutmentZest Anchors, LLC
15 Oct 2025K251294Bonafix Implant AbutmentsZentek Medical LLC
16 Sep 2025K242287SFIT AbutmentCowellmedi Co., Ltd.
2 Sep 2025K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.
20 Aug 2025K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.
20 Aug 2025K250721LOCATOR® Angled AbutmentZest Anchors, LLC
28 Jul 2025K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta Ltd.
28 Jul 2025K241183ISO AbutmentSeum Medi Co., Ltd.
26 Jun 2025K250967SherlockOpen Implants
24 Jun 2025K243009MIST ICImagine Milling Technologies, LLC
16 Jun 2025K242978Geo AbutmentGeoMedi Co., Ltd.
30 May 2025K243530Dynamic TiBaseTalladium Espana, SL
27 May 2025K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.
22 May 2025K250639DESS Dental Smart SolutionsTerrats Medical, S.L.
8 May 2025K243824Preat AbutmentsYoung Innovations Inc
1 May 2025K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.
30 Apr 2025K250295Dentsply Sirona Titanium Bases systemDentsply Sirona, Inc.
22 Apr 2025K242542Medentika CAD/CAM AbutmentsInstitut Straumann AG
11 Apr 2025K250081Atlantis® Abutments in TitaniumDentsply Sirona, Inc.
4 Mar 2025K232383iPhysio® SystemEuroteknika
21 Feb 2025K243278Custom AbutmentsInstitut Straumann AG
19 Feb 2025K243478Straumann InLab Validated WorkflowInstitut Straumann AG
14 Feb 2025K243212DESS Dental Smart SolutionsTerrats Medical, S.L.
17 Jan 2025K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC
14 Jan 2025K243272LOCATOR Angled AbutmentZest Anchors, LLC
13 Jan 2025K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.
8 Jan 2025K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen Inc.
3 Jan 2025K240346NobelProcera Zirconia Implant BridgeNobel Biocare Services AG
19 Dec 2024K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.
17 Dec 2024K241616ALLONUS Tech ProstheticsALLONUS Tech Co., Ltd.
10 Dec 2024K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S
5 Dec 2024K242703LW Pre-milled AbutmentOssvis Co., Ltd.
4 Dec 2024K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.
25 Nov 2024K242245Customized AbutmentARUM DENTISTRY Co., Ltd
11 Nov 2024K241575Straumann® Anatomic Healing Abutments XC (AHA)Institut Straumann AG
5 Nov 2024K242340DESS Dental Smart SolutionsTerrats Medical, S.L.
21 Oct 2024K241170Dynamic TiBase; TRI ScrewsTalladium Espana, SL
18 Oct 2024K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.
9 Oct 2024K241485TruAbutment DS; TruBaseTruAbutment Inc.
18 Sep 2024K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.
13 Sep 2024K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S
26 Aug 2024K240982DESS Dental Smart SolutionsTerrats Medical, S.L.
20 Aug 2024K231932TDS (TECHWIN DENTAL SYSTEM)Techwin Co., Ltd.
30 Jul 2024K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentBioHorizons Implant Systems, Inc.
25 Jul 2024K241063s-Clean ScanHealing AbutmentDentis Co., Ltd.
15 Jul 2024K241032BellaTek BarsBiomet 3i, LLC
12 Jul 2024K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant SystemsPrismatik Dentalcraft, Inc.
7 Jun 2024K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.
5 Jun 2024K240603Ti-Base & Master FixARUM DENTISTRY Co., Ltd
3 Jun 2024K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC
29 May 2024K233389EK Digital AbutmentsHiossen Inc.
24 May 2024K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.
15 May 2024K231940BruxZir® NOW SRCPrismatik Dentalcraft, Inc.
9 May 2024K234112Customized AbutmentARUM DENTISTRY Co., Ltd
7 May 2024K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona, Inc.
2 May 2024K233857Neodent Implant System – Custom AbutmentsInstitut Straumann AG
30 Apr 2024K232528Protective CapNeobiotech Co., Ltd.
24 Apr 2024K240208DESS Dental Smart SolutionsTerrats Medical, S.L.
15 Apr 2024K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsInstitut Straumann AG
26 Mar 2024K231132J & P Click AttachmentsJ & P Dental Technologies
25 Mar 2024K233167LW Implant System – AbutmentOssvis Co., Ltd.
9 Mar 2024K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)
5 Mar 2024K231210DGA AbutmentModern Dental Laboratory Co., Ltd.
1 Mar 2024K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie
21 Feb 2024K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.
20 Feb 2024K233194TS Abutment SystemOsstem Implant Co., Ltd.
24 Jan 2024K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare Services AG
22 Jan 2024K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown ScrewMegagen Implant Co., Ltd.
12 Jan 2024K232170Ti Link AbutmentIzenimplant Co., Ltd.
5 Jan 2024K233316DESS Dental Smart SolutionsTerrats Medical, S.L.
4 Jan 2024K231072Anthogyr FlexiBase® titanium bases for Axiom® BLInstitut Straumann AG
21 Dec 2023K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S
20 Dec 2023K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.
19 Dec 2023K232560Angled AbutmentARUM DENTISTRY Co., Ltd
13 Dec 2023K231803Neodent Implant System - Zirconia Implant SystemInstitut Straumann AG
8 Dec 2023K232750BTI Interna Prosthetic ComponentsB.t.i. Biotechnology
5 Dec 2023K232220SS Abutment SystemOsstem Implant Co., Ltd.
21 Nov 2023K232546Meta G UCLA AbutmentCowellmedi Co., Ltd.
17 Nov 2023K231559Multi-Unit DAS SystemTalladium Espana, SL
14 Nov 2023K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant SystemsPrismatik Dentalcraft, Inc.
30 Oct 2023K231874AOT & T-L AbutmentTruAbutment Inc.
26 Oct 2023K232271SIMDA abutmentSimda Co., Ltd.
17 Oct 2023K232151Dynamic TiBaseTalladium Espana, SL
10 Oct 2023K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.
2 Oct 2023K221972Warantec Custom AbutmentWARANTEC Co., Ltd.
26 Sep 2023K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant SystemsPrismatik Dentalcraft, Inc.
15 Sep 2023K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.t.i. Biotechnology
15 Sep 2023K231235LW UCLA AbutmentOssvis Co., Ltd.
14 Sep 2023K231079LW Retraction CapOssvis Co., Ltd.
1 Sep 2023K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S
24 Aug 2023K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.
18 Aug 2023K220253Eco Abutment, Multiunit AbutmentDIO Corporation
15 Aug 2023K231455Implant-One SystemImplant Logistics, Inc.
14 Aug 2023K231434DESS Dental Smart SolutionsTerrats Medical, S.L.
4 Aug 2023K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.
1 Aug 2023K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants, Inc.
14 Jul 2023K222026Neodent Implant System - Zirconia Implant SystemInstitut Straumann AG
14 Jul 2023K221673Bonafix TiBaseZentek Medical LLC
11 Jul 2023K230307Dentis i-Clean SystemDentis Co., Ltd.
20 Jun 2023K223535SMARTbase Abutment SystemImplant Direct
25 May 2023K230246Dentis s-Clean SQ-SL Narrow Implant SystemDentis Co., Ltd.
24 May 2023K230523s-Clean Link Abutment NarrowDentis Co., Ltd.
24 May 2023K223663SIMDA AbutmentSimda Co., Ltd.
15 May 2023K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG
12 May 2023K221969IU Implant System AbutmentWARANTEC Co., Ltd.
3 May 2023K230203Dentis I-FIX AbutmentDentis Co., Ltd.
28 Apr 2023K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare Services AG
28 Apr 2023K223634Customized AbutmentARUM DENTISTRY Co., Ltd
28 Apr 2023K222636ET Abutment SystemHiossen Inc.
25 Apr 2023K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH
24 Apr 2023K230103Klockner AbutmentsSoadco, S.L.
17 Apr 2023K222469TIB AbutmentsSouthern Implants, Inc.
13 Apr 2023K230143DESS Dental Smart SolutionsTerrats Medical, S.L.
6 Apr 2023K230069S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.
23 Mar 2023K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.
22 Mar 2023K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.
9 Mar 2023K221301DESS Dental Smart SolutionsTerrats Medical, S.L.
7 Feb 2023K222451SAVE GBRDentis Co., Ltd.
3 Feb 2023K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.
13 Jan 2023K222913s-Clean Link AbutmentDentis Co., Ltd.
12 Jan 2023K222976MU SystemDentis Co., Ltd.
11 Jan 2023K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH
29 Dec 2022K222984BioClean Implant Restorative SystemBioclean Dental, LLC
2 Dec 2022K220390CreoDent Solidex Customized Abutment and ScrewCreoDent Prosthetics LTD
1 Dec 2022K222368MIST ICImagine Milling Technologies, LLC
30 Nov 2022K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S
10 Nov 2022K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.
27 Oct 2022K222288DESS Dental Smart SolutionsTerrats Medical, S.L.
26 Oct 2022K222269DESS Dental Smart SolutionsTerrats Medical, S.L.
26 Oct 2022K220823Preat AbutmentsYoung Innovations Inc
21 Oct 2022K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.
20 Oct 2022K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.t.i. Biotechnology
23 Sep 2022K202144A.B. Dental Devices Dental Implants SystemA.B. Dental Device , Ltd.
16 Sep 2022K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG
15 Sep 2022K221966Dynamic TiBaseTalladium Espana, SL
8 Sep 2022K221684Osstem Abutment SystemOsstem Implant Co., Ltd.
10 Aug 2022K221381KDG AbutmentsKeystone Dental Inc.
29 Jul 2022K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG
14 Jul 2022K213961TruAbutment DS, TruBaseTruAbutment Inc.
5 Jul 2022K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)
21 Jun 2022K220482SherlockOpen Implants
16 Jun 2022K220878Straumann TLX Variobase CInstitut Straumann AG
16 Jun 2022K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.
6 Jun 2022K220612PrimeLOC Attachment SystemInnovative Product Brands, Inc.
2 Jun 2022K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG
17 May 2022K211396Neoss Individual ProstheticsNeoss AB
14 Apr 2022K220252High Retention Attachment SystemZest Anchors, LLC
8 Apr 2022K213063TLX SRAs and TLX Gold AbutmentsInstitut Straumann AG
1 Apr 2022K213432MIS Angulated multi-unit abutmentsDentsply Sirona, Inc.
11 Mar 2022K212628DESS Dental Smart SolutionsTerrats Medical, S.L.
3 Mar 2022K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)
4 Feb 2022K210356Noris Medical Dental Implants SystemNoris Medical Ltd.
3 Feb 2022K210826Healing Abutment, Cover ScrewMegagen Implant Co., Ltd.
25 Jan 2022K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.
11 Jan 2022K213391High Retention Attachment SystemZest Anchors, LLC
21 Dec 2021K212730BellaTek Encode Emergence Healing AbutmentsBiomet 3i, LLC
10 Dec 2021K212577DESS Dental Smart SolutionsTerrats Medical, S.L.
30 Nov 2021K212664SherlockOpen Implants
18 Nov 2021K211871FAICO Dental Implant System and CAD/CAM AbutmentsFaico Medical, LLC
15 Nov 2021K213449DS Implants abutments provided with the EV connectionDentsply Sirona, Inc.
20 Oct 2021K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.
9 Oct 2021K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG
24 Sep 2021K212108Dynamic TiBaseTalladium Espana, SL
15 Sep 2021K203649TruAbutment DS, TruBaseTruAbutment Inc.
10 Sep 2021K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.

Showing the 200 most recent of 716.

Official records: FDA product classification for NHA · 21 CFR 872.3630.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026