Dental implants: manufacturers and brands
233 companies make or specify dental implants among the 262 that list one with FDA, under 8,631 brand and model names. FDA has issued 1,550 510(k) clearances in this category, 159 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental implant manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | BLC Implant 3.75mm RB, SLA® 18mm, Roxolid® · BLC Implant 3.75mm RB, SLActive® 18mm, Roxolid® · BLC Implants · BLT 3.3 NC, SLActive 18mm, TiZr, Loxim · +82 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | C1 · Implant · MIS C1 Narrow Platform Conical Connection Implant System · MIS C1 Wide Platform Conical Connection Abutments · +8 | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | Abutment Screw · Closed-Tray Impression Screw · Closed-Tray Tranfer 3.5 x 3.5 x 8 · Closed-Tray Transfer 4.5 x 4.5 x 8 · +522 | 56 | 2026 |
| Terrats Medical, S.L. | Spain | Maker | Terrats Medical S.L. | 23 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | DENTIS DENTAL IMPLANT SYSTEM · Dentis s-Clean s-Line · Dentis s-Clean s-Line Mini · Dentis s-Clean SQ-SL Fixture · +8 | 37 | 2026 |
| ARUM DENTISTRY Co., Ltd | South Korea | Maker | Abutment Screw · Angled Abutment · Angled Abutment Mini · Cemented Abutment · +28 | 17 | 2025 |
| Megagen Implant Co., Ltd. | South Korea | Maker | Abutment Screw · Advanced Intermezzo System · AnyOne External Implant System · AnyOne Internal Implant System · +18 | 30 | 2026 |
| Nakanishi, Inc. | Japan | Maker | — | 37 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | Abutment Screw · Abutment Screw Branemark System · Branemark System Cover Screws · Branemark System Mk III TiU Implants · +71 | 94 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | AVANA DENTAL IMPLANT SYSTEM · EK Dental Implants and Abutments · EK Multi Angled 30 Degree Abutment · EM Provisional · +25 | 68 | 2026 |
| Elos Medtech Pinol A/S | Denmark | Maker | Abutment Blank · Abutment Retrieval Tools/Instruments Titanium · Bone Mill for N1 Trioval Conical Connection · Bone Mill Guide for N1 · +13 | 14 | 2026 |
| Izenimplant Co., Ltd. | South Korea | Maker | ZENEX Implant System · ZENEX Implant System_Long · ZENEX Implant System_Narrow · ZENEX Implant System_R-System · +2 | 8 | 2026 |
| GC America Inc. | United States | Maker | GC Aadva Implant System · JNE Implant System | 137 | 2026 |
| Hiossen Inc. | United States | Maker | EK D3.3 and Ultra Wide Dental Implants · EK Dental Implants and Abutments · EK Multi Angled 30 Degree Abutment · EM Provisional · +13 | 26 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Cowellmedi Co., Ltd. | South Korea | Maker | INNO SLA Mini Plus® Implant System · INNO SLA Sub Narrow Implant System · INNO SLA Submerged Implant System | 14 | 2025 |
| Ossvis Co., Ltd. | South Korea | Maker | LL Implant System · LL Mini Onebody Implant · LL Temporary Cap · LW Abutment Screw · +22 | 7 | 2024 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Southern Implants, Inc. | South Africa | Maker | Co-Axis Implants · DC Implants and Accessories · Deep Conical Implants and Accessories · External hex anatomical abutments · +40 | 22 | 2024 |
| BioHorizons Implant Systems, Inc. | United States | Maker | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM · BioHorizons Dental Implant System · BioHorizons Internal Implant System · BioHorizons Laser-Lok 3 Implant System · +19 | 41 | 2026 |
| B.t.i. Biotechnology | Spain | Maker | — | 14 | 2024 |
| Chengdu Besmile Medical Technology Co., Ltd. | China | Maker | BIORES Dental Implant System | 5 | 2026 |
| Stryker | United States | Maker | add name · Leibinger IMF Screws · Stryker Leibinger Skeletal Anchorage System | 33 | 2024 |
| Noris Medical Ltd. | Israel | Maker | — | 8 | 2025 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | Advanced + Dental Implant System · Advanced + Dia 3.25mm Dental Implant System · Advanced + NP Dental System · Advanced Dia 3.25mm Dental Implant System · +31 | 7 | 2025 |
| Paragon Implant Mfg., LLC | United States | Maker | GEN5 and GEN5+ 3.3mm Implants · GEN5 Implants and Prosthetics · GEN5+ Implants and Prosthetics · NizLoc · +2 | 4 | 2026 |
| S.i.n. - Sistema de Implante Nacional S.A. | Brazil | Maker | S.I.N. Dental Implant System · Sistema de Implante Nacional (S. I. N.) Dental Implant System | 4 | 2025 |
| Implant Direct | United States | Maker | InterActive/SwishPlus2 Implant System · K061319 · K080633 · K080713 · +9 | 24 | 2023 |
| Young Innovations Inc | United States | Maker | Preat Abutments | 23 | 2025 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Bio · Blue Sky Bio Dental Implant System · Blue Sky Bio Dental Implant System - Bio / Conus · Blue Sky Bio Dental Implant System - Double Hex 3 Platform · +7 | 20 | 2024 |
| Park Dental Research Corp | United States | Maker | LEW Mini O-Ball Implant · STARTANIUS DENTAL IMPLANT SYSTEM · StarVent Internal Hex Screw Implant · StarVent Internal Hex Screw Implant Abutments | 8 | 2026 |
| Shinhung Mst Co., Ltd. | South Korea | Maker | MagDen Implant System · SI · SM · ST | 7 | 2023 |
| Keystone Dental Inc. | United States | Maker | Arcitexture Surface Technology · Co Axis · Co-Axis Implant · Endosseous Dental Implant System · +32 | 7 | 2024 |
| Jdentalcare Srl | Italy | Maker | Abutment JDEvolution S · Abutment JDIcon · Abutment JDIcon Ultra S · Anatomic Abutment Angulated 15 H 1.5 JDEvolution Plus · +255 | 5 | 2025 |
| Imagine Milling Technologies, LLC | United States | Maker | SIC invent Dental Implant Systems · SICtapered & SICvantage tapered | 4 | 2026 |
| ADIN DENTAL IMPLANT SYSTEMS Ltd | Israel | Maker | Adin Dental Implants System · Adin Short Implants · ADIN UNIFIT DENTAL IMPLANT SYSTEM · Anatomic Abutments · +70 | 3 | 2026 |
| Zentek Medical LLC | United States | Maker | Bonafix 2 Plus · Dentlot · Duranext Duo · Zentek · +1 | 3 | 2025 |
| Neobiotech Co., Ltd. | South Korea | Maker | CMI implant EB System · CMI Implant IS II active · CMI IMPLANT IS SYSTEM · CMI implant IT System · +6 | 17 | 2024 |
| InnoBioSurg Co.,Ltd | South Korea | Maker | AMII Implant Closing Screw · AMII Implant Healing Cap · AMII Implant Healing Cap Screw · AMII Implant System · +1 | 15 | 2022 |
| Hager& Meisinger GmbH | Germany | Maker | Dental Implant OKTAGON · Dental Implants OKTAGON Bone Level Tapered Design · myplant two Abutment · myplant two Ball Anchor · +11 | 14 | 2025 |
| Biotem Co., Ltd. | South Korea | Maker | AR_N SLA Type Implant System · AR_N Type Implant System · Bone Level Fixture · BR SLA Type Implant System · +4 | 6 | 2023 |
| SIC invent AG | Switzerland | Maker | 951378 · 951416 · 951417 · 951422 · +9 | 5 | 2026 |
| WARANTEC Co., Ltd. | South Korea | Maker | CD-38 · CD-43 · CD-53 · CRD-N8.5 · +873 | 4 | 2023 |
| TRI Dental Implants Int. AG | Switzerland | Maker | TRI Dental Implant System · TRI Matrix X-Force · TRI-matrix Implant Line | 3 | 2025 |
| SNUCONE Co., LTD. | South Korea | Maker | SNUCONE BONE LEVEL IMPLANT SYSTEM · SNUCONE TISSUE LEVEL IMPLANT SYSTEM | 2 | 2023 |
| Ditron Dental Ltd | Israel | Maker | Abutment, Implant, Dental Endosseous · Accelx cover screws · Accelx dental implants · Bar Retained Abutments, Multi-Unit Bar Retained Abutments, Screw Retained Abutment, Cover Screw, Healing Cap · +24 | 2 | 2024 |
| ZEROS Co., Ltd. | South Korea | Maker | STERI-OSS Implant System · ZEROS Dental Implant System | 2 | 2026 |
| Oneday Biotech Co., Ltd. | South Korea | Maker | I DO IMPLAMT · Oneday Biotech Implant · Oneday Mini Implant System | 2 | 2024 |
| newton implant systems | United States | Maker | implant, endosseous, root-form · Ni2 Newton Implant Systems | 2 | 2024 |
| Unidental Co., Ltd. | South Korea | Maker | UNIdental Symphony Implant System | 2 | 2026 |
| Infinitum Eta Ltd. | Israel | Maker | — | 2 | 2025 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| Dentium USA | United States | Maker | BNO1 · BNO2 · BPF2 · BPF3 · +243 | 23 | 2022 |
| DIO Corporation | South Korea | Maker | DIO Ball Cap · DIO Dental Implant System · Dio Protem Implant System · DIO Retainer · +134 | 14 | 2023 |
| KJ Meditech Co., Ltd. | South Korea | Maker | Anchor plus · Conical Plus Implant System · HERO I DENTAL IMPLANT SYSTEM · HERO II DENTAL IMPLANT SYSTEM · +17 | 13 | 2022 |
| Neoss AB | Sweden | Maker | — | 10 | 2022 |
| Jeil Medical Corporation | South Korea | Maker | Dual Top | 9 | 2026 |
| Soadco, S.L. | Andorra | Maker | Essential Cone (EC) · Essential ECK · Essential Solid (ES) · KLOCKNER DENTAL IMPLANT S3 · +9 | 9 | 2023 |
| A.B. Dental Devices , Ltd. | Israel | Maker | A.B. Dental Device, Ltd. · AB Dental Devices Dental Implants · AB LOC H1mm Conical Platform · AB LOC H2mm Conical Platform · +201 | 4 | 2026 |
| Alpha-Bio Tec | Israel | Maker | Abutment Screw - CS · Adhesive Coping for D3.5 MU · Angled Ti abutment 10 ° 1.5 CHC · Angled Ti abutment 10 ° 1.5 CS · +142 | 4 | 2026 |
| Leone S.P.A. | Italy | Maker | LEONE IMPLANT SYSTEM | 4 | 2025 |
| Alpha Dent Implants GmbH | Germany | Maker | dental Implant " Implant Classic_" · Dental implant "Zahntium Implant" · DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABP · dental implants "Implant Active Bio_" · +88 | 3 | 2024 |
| BIO CONCEPT Co., Ltd | China | Maker | BLT Dental Implant System · BV Dental Implant System · Dental Implant System | 3 | 2022 |
| Surgikor, LLC | United States | Maker | Abutment Screw · Anatomic Straight Abutment · Anti-Rotation Abutment · Ball Attachment Abutment · +30 | 2 | 2024 |
| Uniqa Dental, Ltd. | Israel | Maker | Ball attachment abutment · Conical Implant, Internal Hex, Pure & Porous, P&P · Conical Implant, Internal Hex, SBA · Conical Implant, Pure & Porous, P&P · +51 | 2 | 2026 |
| Sewon Medix, Inc. | South Korea | Maker | BIOTHREAD BT3 Implant System · IH Implant System | 2 | 2023 |
| DSI Dental Solutions Ltd | Israel | Maker | DSI Dental Implant System | 2 | 2025 |
| Biotech Dental | France | Maker | Kontact Dental Implant System · KontactTM Dental Implant System | 2 | 2022 |
| Avinent Implant System S.L.U. | Spain | Maker | AVINENT IMPLANT SYSTEM | 2 | 2026 |
| Osseofuse International Inc. | United States | Maker | HexaPLUS S · HexaPLUS S OneDrill Implant System | 2 | 2025 |
| Eclectic Co., Ltd. | South Korea | Maker | PreXolid Angled Abutment 4.50mm H80mm GH0.80mm, AAM 17451A · PreXolid Angled Abutment 4.50mm H80mm GH0.80mm, AAR 17451A · PreXolid Angled Abutment 4.50mm H80mm GH1.80mm, AAM 17452A · PreXolid Angled Abutment 4.50mm H80mm GH1.80mm, AAR 17452A · +350 | 1 | 2024 |
| Mozograu S.A. | Spain | Maker | Ticare Dental Implant Systems | 1 | 2024 |
| ZimVie US Corp LLC | United States | Maker | AdVent · Bellatek Abutment TSV · Certain Cover Screw · Certain Flat Implant Cover Screw · +93 | 1 | 2026 |
| Cybermed Inc. | South Korea | Maker | CORE1 Implant System · REBORN ImplantSystem | 1 | 2022 |
| Ceraroot SL | Spain | Maker | CeraRoot · CeraRoot ceramic implant · CeraRoot surgical kit · CeraRoot zirconium oxide dental implant | 1 | 2025 |
| DIMPLO Ltd. | South Korea | Maker | DIMPLO Implant System | 1 | 2025 |
| Bioline Dental Implant Systems Ltd | Israel | Maker | Bioline Dental Implant System | 1 | 2025 |
| Inosys, Inc. | United States | Maker | Abutment Screw · Cemented Abutment (HEX) · Cemented Abutment (NON-HEX) · Closing Screw · +7 | 1 | 2026 |
| Alien Milling Technologies | United States | Maker | Genesis ACTIVE Implant System | 1 | 2024 |
| Biotech Dental | United States | Maker | Kontact · Reflect | 1 | 2024 |
| Roott LLC | United States | Maker | TRATE DENTAL IMPLANT SYSTEM · TRATE DENTAL IMPLANT SYSTEM - ROOT IMPLANT AND ABUTMENT | 1 | 2022 |
| Surcam Medical Devices and Developments Ltd | Israel | Maker | Surcam Dental Implant System | 1 | 2025 |
| d.a.n.d metal industries north LTD | Israel | Maker | DAND Dental Implant System | 1 | 2025 |
| DenQ Co., Ltd. | South Korea | Maker | DenQ Sub SLA Implant System | 1 | 2024 |
| IDIS Co. Ltd. | South Korea | Maker | Ni2 Implant System · S-Plant Dental Implant System | 1 | 2023 |
| Quickdent Devices Private Limited | India | Maker | Quickdent Dental Implant System | 1 | 2024 |
| RDJ TOV Implant Ltd | Israel | Maker | TOV Dental Implant System | 1 | 2024 |
| highness Co.,Ltd. | South Korea | Maker | HIGHNESS IMPLANT SYSTEM | 1 | 2024 |
| OsteoCentric Technologies Inc | United States | Maker | OsteoCentric Dental Implant System | 1 | 2023 |
| Z7 LLC | United States | Maker | ZiNova Implants | 1 | 2023 |
| Thommen Medical AG | Switzerland | Maker | Implants PF6/L6.5 · SPI Contact PF 4 · SPI ELEMENT · SPI ELEMENT INICELL, SPI CONTACT INICELL · +5 | 26 | 2017 |
| Sterngold | United States | Maker | Acid Etch Implant System · ERA Dental Implant System · ERA Implant · ERA Implant Abutment · +21 | 24 | 2017 |
| Bicon, LLC | United States | Maker | Bicon Implant · Integra-CP · Integra-Ti · MAX 2.5 Implant System · +8 | 18 | 2015 |
| CAMLOG Biotechnologies GmbH | Switzerland | Maker | — | 14 | 2020 |
| Zimmer Inc | United States | Maker | IMF SCREW · LORENZ · SELF-DRILLING | 14 | 2001 |
| Medtronic, Inc. | United States | Maker | ARCHITEX | 11 | 2014 |
| Biodenta Swiss AG | Switzerland | Maker | Biodenta Dental Implant System · Biodenta Dental Implant System - Bone Level D 3 to 6 mm · Biodenta Dental Implant System (Bone Level Tapered) · Biodenta Dental Implant System (Bone Level) · +1 | 11 | 2015 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| Biomet Microfixation | United States | Maker | Self Drilling IMF Screw | 8 | 2021 |
| Z-Systems AG | Switzerland | Maker | Z5-BL · Z5-TL · Z5c · Z5m · +3 | 8 | 2020 |
| SWEDEN & MARTINA S.p.A. | Italy | Maker | ABUTMENT PLAIN SCREW M2 · ABUTMENT PLAIN SCREWS M2 · ABUTMENT SCREW · ABUTMENT SCREW M1.8 · +312 | 6 | 2019 |
| Basic Dental Implant Systems, Inc. | United States | Maker | Basic Dental Implant System | 6 | 2008 |
| Medartis AG | Switzerland | Maker | MODUS IMF Screws 2 | 6 | 2007 |
| Rhein'83 Srl | Italy | Maker | SPHERO FLEX AND BLOCK; OT EQUATOR PROFILE; | 4 | 2018 |
| Cortex Dental Implants Industries Ltd. | Israel | Maker | BCDL-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 · +158 | 4 | 2019 |
| Medimecca Co., Ltd. | South Korea | Maker | Biothread Dental Implant System · Biothread Dental Implant Systems · CHAORUM Implant System · DISOAR Implant System · +5 | 4 | 2020 |
| CSM Implant | South Korea | Maker | CSM Submerged3-L Implant System · implant1 · implant2 · implant3 | 4 | 2018 |
| Oco Biomedical | United States | Maker | IMMEDIATE STABLIZING IMPLANT (ISI) · SMALL DIAMETER IMPLANT (SDI) · TSI / ERI; ENGAGE / ENGAGE PLUS · 3 DENTAL IMPLANT | 4 | 2013 |
| Titan Implants, Inc. | United States | Maker | TITAN IMPLANTS | 4 | 2005 |
| KAT Implants, LLC | United States | Maker | Angled Abutment 4.2 10º · Angled Abutment 4.2 20º · Angled Abutment 4.6 10º · Angled Abutment 4.6 20º · +44 | 3 | 2012 |
| OT medical GmbH | Germany | Maker | CreativeLine · NaturalLine · OT-F² Implants · OT-F³ Implants · +2 | 3 | 2016 |
| Odontit S.A. | Argentina | Maker | Kalos Biomedical · ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE | 3 | 2014 |
| Hdc S.R.L. | Italy | Maker | SPIDER SCREW · STERILE SPIDER SCREW | 3 | 2009 |
| TAV Medical | Israel | Maker | TAV Dental Implant System | 3 | 2019 |
| DiamoDent | United States | Maker | UCLA | 3 | 2004 |
| Dentos, Inc. | South Korea | Maker | ABSO ANCHOR MICROIMPLANT | 2 | 2019 |
| S.G.S. International Ltd | Hungary | Maker | Abutments Plastic for Casting with Titanium Base & Hex · Adaptor · Anatomic Angular Abutment · Anatomic Angular Abutment for 7PN · +79 | 2 | 2019 |
| Ritter Implants GmbH and Co. KG | United States | Maker | Ritter Dental Implant System · Ritter Dentals · Ritter Implant system small sizes | 2 | 2019 |
| Suncoast Dental Corp. | United States | Maker | Suncoast Dental, Inc. · Suncoast Dental, Inc. Dba Tatum Surgical | 2 | 1981 |
| Cendres+Metaux SA | Switzerland | Maker | TRI Dental Implant System · TRI-matrix Implant Line | 2 | 2020 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| Hung Chun Bio-S Co., Ltd. | Taiwan | Maker | Ti-One 101 Dental Implant System · TIONE 101 Dental Implant System · TIONE TS Dental Implant System | 2 | 2018 |
| Alliance Global Technology Co., Ltd. | Taiwan | Maker | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS · IMPLANT, ENDOSSEOUS, ROOT-FORM | 2 | 2016 |
| Zuga Medical, Inc. | United States | Maker | Zuga · Zuga Medical Dental Implant System | 2 | 2018 |
| Implacil DE Bortoli Material Odontologico Ltda | Brazil | Maker | Abutment, Implant, Dental, Endosseous - Implacil Implant System · Implacil Implant System · Implant, Endosseous, Root-Form - Implacil Implant System | 2 | 2021 |
| American Dental Implant Corporation | United States | Maker | ADI Bone Drill · American Dental Implant | 2 | 2008 |
| Sudimplant SA | France | Maker | TBR IDE@ CONIC · TBR Zirconnect | 2 | 2007 |
| Dental Evolutions, Inc. | United States | Maker | Implanova | 2 | 2021 |
| BEGO Implant Systems GmbH & Co. KG | Germany | Maker | — | 2 | 2021 |
| SDS Swiss Dental Solutions AG | Switzerland | Maker | — | 2 | 2020 |
| TAG Medical products corporation LTD | United States | Maker | Anatomic Abutment H1mm L4mm · Anatomic Abutment H1mm L6mm · Anatomic Abutment H1mm L8mm · Anatomic Abutment H2mm L4mm · +397 | 1 | 2015 |
| Hi-Tec Implants | Israel | Maker | AAT · AAT-L · ACA · ACA-0 · +381 | 1 | 1994 |
| Abracadabra Implants Ltd. | Israel | Maker | BO0833 - 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 · +79 | 1 | 2021 |
| DENTIN Implants Technologies Ltd. | Israel | Maker | Abutment System · Aesthetic Minor Unit · Anatomic Angulated Titanium Abutment · Anatomic Titanium Abutment · +22 | 1 | 2012 |
| Nova Implants | Israel | Maker | ANG Anatomic Angulated Abutment · ANTAnatomic Angulated Curve · ASM Angulated Abutment · BAT Ball Attachment · +16 | 1 | 2015 |
| Iq Implants , Ltd. | Israel | Maker | Aesthetic Abutments · Anatomic Angled Abutments 15 Degrees · Anatomic Angled Abutments 25 Degrees · Angled Abutments 15 Degrees · +15 | 1 | 2013 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | Abutment Retrieval Kit | 1 | 2007 |
| T Strong, Inc. | South Korea | Maker | U fit Dental Implant System | 1 | 2014 |
| Ziacom Medical, S.L. | Spain | Maker | CORVEN · Ziacom Zinic · Ziacom Zinic MT · Ziacom Zinic MTX · +1 | 1 | 2019 |
| Bioseal | United States | Maker | Implanova | 1 | 1988 |
| Dental Crafters Inc. | United States | Maker | Genesis ACTIVE Abutments · K3Pro Customized Abutments | 1 | 2009 |
| Medical Systems and Devices International Ltd. | Israel | Maker | Alef, Kaf, Taf MSDI Dental Implants System | 1 | 2020 |
| alfa gate - mazen ltd. | Israel | Maker | Alfa Gate | 1 | 2019 |
| F&B Technology Co., Ltd. | South Korea | Maker | Fit & Brilliant Dental Implant System | 1 | 2020 |
| GP Implants Ltd | Israel | Maker | GP Implant System | 1 | 2017 |
| Jiangsu Trausim Medical Instrument Co.,Ltd. | China | Maker | Trausim Dental Implant System | 1 | 2014 |
| Tita-Link | Belgium | Maker | Bollard Mini Plates | 1 | 2009 |
| 8dent Inc. | South Korea | Maker | ADD-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. | Israel | Maker | ABA1801 · ABA1802 · ABA1803 · ABA3001 · +452 | — | — |
| Sotera Health LLC | United States | Maker | Atlas Implant Packs · Celsite® Discreet STL201H · CERTAIN® FLAT IMPLANT COVER SCREW · CERTAIN® IMPLANT HEADLESS COVER SCREW · +302 | — | — |
| Noga Medical Products Ltd. | Israel | Maker | Axis Implant ø3.30 L10mm · Axis Implant ø3.30 L11.50mm · Axis Implant ø3.30 L13mm · Axis Implant ø3.30 L16mm · +206 | — | — |
| Precision One Medical | United States | Maker | BIOHORIZONS DENTAL IMPLANT SYSTEM · BioHorizons Internal Implant · BIOHORIZONS INTERNAL IMPLANT SYSTEM · BioHorizons Single-stage Implant · +115 | — | — |
| Intai Technology Corp. Implants Business Unit | Taiwan | Maker | ADVENT IMPLANT SYSTEM · CASTABLE ABUTMENTS · INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM · INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM · +7 | — | — |
| TruAbutment Korea Co Ltd | South Korea | Maker | URIS Long Implant & Abutments · URIS OMNI Implant · URIS Smart Path Implant System & Prosthetic | — | — |
| D.S.P. Industrial EIRELI EPP | Brazil | Maker | HE ANATOMICAL ABUTMENT · HE ANATOMICAL HEALING ABUTMENT · HE BIOFIT DENTAL IMPLANT · HE COCR BASE UCLA · +30 | — | — |
| PointImplant Co Ltd | South Korea | Maker | Abutment Screw · Angled Abutment · Cemented Abutment · Cover Screw · +7 | — | — |
| ACH Medical Co., Ltd. | South Korea | Maker | AIMGEN · Biogenesis Implant System - Aticon · Biogenesis Implant System - Kisses · IB · +12 | — | — |
| BBF Sterilisationsservice GmbH | Germany | Maker | Ankylos C/X Dental Implant System · Ankylos C/X Implant System · ANKYLOS plus/ ANKYLOS C/X/ XiVE S/ XiVE TG implants · CAMLOG SCREW-LINE IMPLANTS · +17 | — | — |
| Dentatus AB | Sweden | Maker | ANEW · Atlas · MTI Monorail | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Micro Precision Swiss, LLC | United States | Maker | Abutment Retrieval Kit · Abutment Screw Retrieval Instrument · Angulated Abutment · Duo-Dent · +9 | — | — |
| Digital Age Dental Laboratories, Ltd. | United States | Maker | 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) · Biomet 3i Cast-To Gold Abutments (NP Engaging 3.5 mm 2.9 mm) · CONELOG Inset Abutments · +7 | — | — |
| LA Precision Industry | France | Maker | Temporary cylinder EsthetiCone | — | — |
| Elos Medtech AB | Sweden | Maker | Dental Implant Oktagon · OKTAGON Bone Level Implants · OKTAGON Bone Level Tapered Implants | — | — |
| LX Precision Shanghai Co. Ltd. | China | Maker | Biomet 3i Abutment Retaining Screws · N/A · Zimmer Biomet · - · +4 | — | — |
| Laboratorios Dentales de Zona Franca, S.A. | Costa Rica | Maker | Custom Abutment - Hahn | — | — |
| Accumedix, Inc. | United States | Maker | Bio Conus, Bio Max, and Bio Quattro Implant Systems · Blue Sky Bio Dental Implant · Blue Sky Bio Pterygoid Implants and Abutments · Double Hex Implant System · +2 | — | — |
| LX Precision Portugal, Unipessoal, Lda | Portugal | Maker | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT · SCREW-VENT DENTAL IMPLANT SYSTEM · SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT · Spline Implant System · +5 | — | — |
| Dentauspex Corporation | Taiwan | Maker | Biodenta Dental Implant System · Biodenta Dental Implant System (Bone Level) · BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3 TO 6 MM · BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED · +1 | — | — |
| Superior Machined Products, Inc. | United States | Maker | Blue Sky Bio · Intralock · Non-Expandable · Odontit · +3 | — | — |
| Paragon Implant Company, LLC | United States | Maker | GEN5 and GEN5+ Implants · GEN5 Implants and Prosthetics · GEN5+ Implants and Prosthetics · NizLoc · +2 | — | — |
| Frueh Verpackungstechnik AG | Switzerland | Maker | CIM 3.3 mm ND · Contact Implant, healing cap included · Element implant, healing cap included · Implant Endosseous Root-Form · +2 | — | — |
| Millstone Medical Outsourcing LLC | United States | Maker | Dental Implant System · PrimaConnex Dental Implant System · PrimaSolo Dental Implant System · RENOVA Dental Implant System · +2 | — | — |
| Pan-Am Dental, Inc. | United States | Maker | Preat Abutments | — | — |
| R2 Digital Milling Technologies Inc | United States | Maker | ANYONETM INTERNAL IMPLANT SYSTEM · ANYRIDGE INTERNAL IMPLANT SYSTEM · ARi ExCon Implant System | — | — |
| Implant Logistics / AMS Micromedical | United States | Maker | Implant Logistics, Inc · Implant-One | — | — |
| Theia Holding SA | Switzerland | Maker | — | — | — |
| UFP Technologies, Inc. | United States | Maker | IMPLANT, ENDOSSEOUS, ROOT-FORM · MULTIPLE DENTAL IMPLANT SYSTEM · MULTIPLE DENTAL IMPLANT SYSTEMS | — | — |
| GMI Dental Implantology, S.L. | Spain | Maker | GMI Frontier dental implant system | — | — |
| puracon GmbH | Germany | Maker | endosseous implant, root form · IMPLANT, ENDOSSEOUS, ROOT-FORM | — | — |
| ARCH Medical Solutions - Escondido LLC | United States | Maker | Abutment, implant, dental, endosseous · IMPLANT, ENDOSSEOUS, ROOT-FORM | — | — |
| CeramTec Schweiz GmbH | Switzerland | Maker | Zeramex Dental Implant System | — | — |
| GCDL, LLC | United States | Maker | Preat Abutments | — | — |
| Josef Ganter Feinmechanik GmbH | Germany | Maker | — | — | — |
| Argon Dental Vertriebs Gmbh & Co. KG | Germany | Maker | K3Pro Konus Additional Abutments and Implants · K3Pro Konus Dental Implant System | — | — |
| Barksdale Dental | United States | Maker | Preat Abutments | — | — |
| BIODENT INC /Khachi | United States | Maker | EXTERNAL HEX · INTERNALHEX · NON EXPANDABLE · ULTRATOOTH | — | — |
| Daekwang Idm | South Korea | Maker | IMPLANT, ENDOSSEOUS, ROOT-FORMAbutment, implant, dental, endosseous | — | — |
| DMITechnology LLC | United States | Maker | DMI Dental Implant System | — | — |
| Dti Implant Systems | Türkiye | Maker | DTI | — | — |
| Evidence Implant Inc. | South Korea | Maker | Internal Hex Implant System | — | — |
| Precera Medical Inc | United States | Maker | Screw-Vent Dental Implant System · Spline Dental Implant System | — | — |
| ARDS Industries | Israel | Maker | ARDS Dental Implant | — | — |
| Bayou State Crown & Bridge Lab | United States | Maker | Preat Abutments | — | — |
| Gunter Medical GmbH | Germany | Maker | Zuga | — | — |
| Aeton Medical | United States | Maker | ST Abutment Systems | — | — |
| Cenova AB | Sweden | Maker | Atlas/Anew Implant | — | — |
| DOT America, Inc. | United States | Maker | Small Diameter Implant (SDI) · 3 Dental Implant | — | — |
| Louisiana Dental Implant Lab | United States | Maker | Vortex | — | — |
| Maestro Logistics | United States | Maker | Dental Implant System | — | — |
| Roott UAB | Lithuania | Maker | TRATE Dental Implant System | — | — |
| Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi ve Ticaret Anon | Türkiye | Maker | Nucleoss | — | — |
| Selenium Medical S.A.S. | France | Maker | KONTACT DENTAL IMPLANT SYSTEM | — | — |
| Synoross | United States | Maker | OsseOne Dental Implant System | — | — |
| Technovent Limited | United Kingdom | Maker | MagnaCap abutment | — | — |
| AllOnRx | United States | Maker | Vortex | — | — |
| Basic (Chengdu) Medical Device Co., Ltd. | China | Maker | Basic Dental Implant System | — | — |
| COHO Advanced Materials Tech. Co., Ltd. | Taiwan | Maker | — | — | — |
| Dongguan xinlonghong Hardware Co., Ltd | China | Maker | Vortex | — | — |
| EMERY ENTERPRISES INC.dba ITL Dental | United States | Maker | — | — | — |
| FMZ GmbH | Germany | Maker | — | — | — |
| Quality Tech Services, LLC | United States | Maker | — | — | — |
| Arch Medical & Aerospace-Minneapolis, LLC | United States | Maker | — | — | — |
| Ceramaret SA | Switzerland | Maker | — | — | — |
| CeramTec GmbH | Germany | Maker | — | — | — |
| cleanpac Inc. | United States | Maker | — | — | — |
| CPM Precision GmbH | Germany | Maker | — | — | — |
| Diener AG Precision Machining | Switzerland | Maker | — | — | — |
| DOT GmbH | Germany | Maker | — | — | — |
| Eurofins inpac Medizintechnik GmbH | Germany | Maker | — | — | — |
| Faulhaber Pinzetten KG | Germany | Maker | — | — | — |
| Himed, LLC. | United States | Maker | — | — | — |
| Hipp Medical AG | Germany | Maker | — | — | — |
| InfinetaMed AG | Switzerland | Maker | — | — | — |
| Khoury Dent Ltd Via Kasko K.N Ltd | Israel | Maker | — | — | — |
| Laser Integration Laser Applikation GmbH | Germany | Maker | — | — | — |
| LayerWise nv | United States | Maker | — | — | — |
| Microcision LLC | United States | Maker | — | — | — |
| Phen'X Technologies | France | Maker | — | — | — |
| Rickli Micromecanique SA | Switzerland | Maker | — | — | — |
| Samaplast AG | Switzerland | Maker | — | — | — |
| Steripac GmbH | Germany | Maker | — | — | — |
| Wesley Coe (Cambridge) Ltd. | United Kingdom | Maker | — | — | — |
| Smart Denture Conversions, LLC | United States | Manufacturer | Prosthetic Screw, Paltop (IHex) | 2 | 2026 |
| Manufacturera Dental Continental | Mexico | Foreign exporter | Paltop Dental Sterile Accessories · Paltop Dynamic C Dental Implant System · Paltop Narrow Implant, Paltop PCA Dental Implant system | 2 | 2001 |
| Factor, Ii, Inc. | United States | Repacker / relabeler | MAGNABUTMENT | 2 | 2000 |
| Rmo, Inc. | United States | Manufacturer | Dual Top | 1 | 1990 |
| National Dentex LLC | United States | Contract manufacturer | Preat Abutments | 1 | 2012 |
| Sweden & Martina INC | United States | Lister | CAST. NON REP. POST WITH CRCO · CAST. NON REP. POST WITH GOLD · CASTABLE REP. POST WITH CRCO · CASTABLE REP. POST WITH GOLD · +31 | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | DSI Dental Implant System | — | — |
| Swann Morton Limited | United Kingdom | Contract sterilizer | Dental Implant System · Implant System Neo · Neo Implant System · Neoss Implant System 3.25 · +3 | — | — |
| STERIS Corporation | United States | Contract sterilizer | Accumedix377 (LS) - Blue Sky Bio Dental Implant System - Internal Octagon Taper; Blue Sky Bio Dental Implant System · Accumedix3772 (LS) - Blue Sky Bio · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Bio / Conus · +38 | — | — |
| Curitiba Esterilizacao De Materiais Medicos LTDA | Brazil | Contract sterilizer | GM Narrow Implant System · GM Zygomatic Implant System · Helix Short Implant System · Neodent Implant System · +7 | — | — |
| IDOC Dental Lab | United States | Contract manufacturer | DenQ Sub Multi-unit Abutment(Angled-1) DSMAR493017OS · DenQ Sub Multi-unit Abutment(Angled-1) DSMAR494017OS · DenQ Sub Multi-unit Abutment(Angled-1) DSMAR494030OS · DenQ Sub Multi-unit Abutment(Straight) DSMR48302S · +6 | — | — |
| Sor Van Radiation Ltd | Israel | Contract sterilizer | Accelx dental implants · APC (Conical Connection Advanced Precision Implant) · API - Advanced Precision Implant · Axis Implants · +13 | — | — |
| Aragogamma, S.L. | Spain | Contract sterilizer | Advent and Swiss Plus Dental Implant System · Advent Implant System · CERTAIN® PREVAIL® IMPLANT · Eztetic Abutments · +15 | — | — |
| HANSAMED LIMITED dba CITAGENIX | Canada | Foreign exporter | Citagenix | — | — |
| Epione Bidco | France | Contract sterilizer | Anthogyr AXIOM® BL X3 implants · Anthogyr Multi-Unit components for AXIOM® BL · axiom BL 2.8 · axiom BL px · +2 | — | — |
| Dental Plus USA, LLC | United States | Repacker / relabeler | Multi-Unit Analog, Screw, Abutment | — | — |
| Greenpia Technology Inc. | South Korea | Contract sterilizer | J2A Dental Implant System, J2C Dental Implant System · One Plus Implant System · Osseofuse Dental Implant System | — | — |
| Dentaline LLC | United States | Lister | Biodenta · dentaswiss | — | — |
| Greiner Mediscan GmbH | Austria | Contract sterilizer | Prama White Implant Systems · Premium One Implant Systems · Premium Shelta Implant Systems | — | — |
| F.M. Howell & Co. | United States | Repacker / relabeler | BlueSkyBio | — | — |
| LBN Medical ApS | Denmark | Foreign exporter | L8-3 freesyle | — | — |
| MEDEALIS GmbH | Germany | Foreign exporter | DESS Dental Smart Solutions | — | — |
| Medequip Implant Supplies | United States | Repacker / relabeler | Dental implants | — | — |
| Global Dental Transfer Ltd | Israel | Repacker / relabeler | Global Dental Transfer Dental Implant System | — | — |
| Steriservices | France | Contract sterilizer | TITA-LINK | — | — |
| AMG Dental Ltd | Israel | Repacker / relabeler | — | — | — |
| NuVentus AG | Switzerland | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Pharmco Medical B.V. | Netherlands | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental implants are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE | 2 | 872.3640 | 233 | 1,550 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Oct 2026 | K261295 | MultiNeO Dental Implant System | Alpha-Bio Tec | DZE Root-Form Endosseous Implant |
| 17 Sep 2026 | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 19 Aug 2026 | K260463 | ZEROS Dental Implant System | ZEROS Co., Ltd. | DZE Root-Form Endosseous Implant |
| 25 Jun 2026 | K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | DZE Root-Form Endosseous Implant |
| 18 Jun 2026 | K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | DZE Root-Form Endosseous Implant |
| 18 Jun 2026 | K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | DZE Root-Form Endosseous Implant |
| 17 Jun 2026 | K260006 | INOSS System | Inosys, Inc. | DZE Root-Form Endosseous Implant |
| 12 May 2026 | K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | DZE Root-Form Endosseous Implant |
| 23 Mar 2026 | K252031 | Adin Long Dental Implant System | ADIN DENTAL IMPLANT SYSTEMS Ltd | DZE Root-Form Endosseous Implant |
| 16 Mar 2026 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | DZE Root-Form Endosseous Implant |
| 10 Mar 2026 | K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 4 Mar 2026 | K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | DZE Root-Form Endosseous Implant |
| 18 Feb 2026 | K252197 | Nobel Biocare S Series Implants | Nobel Biocare Services AG | DZE Root-Form Endosseous Implant |
| 2 Feb 2026 | K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | DZE Root-Form Endosseous Implant |
| 8 Jan 2026 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | DZE Root-Form Endosseous Implant |
| 23 Dec 2025 | K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 23 Dec 2025 | K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 22 Dec 2025 | K251605 | DIMPLO Implant System | DIMPLO Ltd. | DZE Root-Form Endosseous Implant |
| 12 Dec 2025 | K252090 | Pterygoid Indication for GM Helix Implants | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 7 Nov 2025 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.i.n. - Sistema de Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 30 Oct 2025 | K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 10 Oct 2025 | K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International Inc. | DZE Root-Form Endosseous Implant |
| 29 Sep 2025 | K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions Inc. | DZE Root-Form Endosseous Implant |
| 26 Sep 2025 | K251262 | S.I.N. Dental Implant System | S.i.n. - Sistema de Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 25 Sep 2025 | K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | DZE Root-Form Endosseous Implant |
| 25 Aug 2025 | K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare Services AG | DZE Root-Form Endosseous Implant |
| 21 Aug 2025 | K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | Dentsply Sirona, Inc. | DZE Root-Form Endosseous Implant |
| 18 Aug 2025 | K250271 | Neodent Implant System - Zirconia Implant System | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 13 Aug 2025 | K251046 | S.I.N. Dental Implant System | S.i.n. - Sistema de Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 12 Aug 2025 | K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 24 Jul 2025 | K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | DZE Root-Form Endosseous Implant |
| 23 Jul 2025 | K251280 | DESS® Dental Implants | Terrats Medical, S.L. | DZE Root-Form Endosseous Implant |
| 23 Jul 2025 | K250280 | SD TL Implant System | ARUM DENTISTRY Co., Ltd | DZE Root-Form Endosseous Implant |
| 9 Jul 2025 | K243731 | HEXIM Implant; Samwon General Abutments | P&a Usa | DZE Root-Form Endosseous Implant |
| 3 Jul 2025 | K243255 | URIS Long Implant & Abutments | TruAbutment Inc. | DZE Root-Form Endosseous Implant |
| 27 Jun 2025 | K251660 | T3 Pro Implants ZimVie Packaging System | Biomet 3i, LLC | DZE Root-Form Endosseous Implant |
| 18 Jun 2025 | K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems Ltd | DZE Root-Form Endosseous Implant |
| 6 Jun 2025 | K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | DZE Root-Form Endosseous Implant |
| 14 May 2025 | K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | DZE Root-Form Endosseous Implant |
| 8 May 2025 | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | DZE Root-Form Endosseous Implant |