Prosthetic devices · 21 CFR 872 Subpart D
Root-Form Endosseous Implant
FDA device type “Implant, Endosseous, Root-Form”.
- Companies listing it
- 262233 makers
- Brands and models
- 8,631
- 510(k) clearances
- 1,550159 in five years
- FDA name
- Implant, Endosseous, Root-Form
510(k) clearances per year, 1976–2026
Companies that list DZE
262 companies currently list this device type with FDA.
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 22 Oct 2026 | K261295 | MultiNeO Dental Implant System | Alpha-Bio Tec |
| 17 Sep 2026 | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC |
| 19 Aug 2026 | K260463 | ZEROS Dental Implant System | ZEROS Co., Ltd. |
| 25 Jun 2026 | K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. |
| 18 Jun 2026 | K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. |
| 18 Jun 2026 | K250806 | Dental Implant System | A.B. Dental Devices , Ltd. |
| 17 Jun 2026 | K260006 | INOSS System | Inosys, Inc. |
| 12 May 2026 | K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB |
| 23 Mar 2026 | K252031 | Adin Long Dental Implant System | ADIN DENTAL IMPLANT SYSTEMS Ltd |
| 16 Mar 2026 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. |
| 10 Mar 2026 | K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG |
| 4 Mar 2026 | K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. |
| 18 Feb 2026 | K252197 | Nobel Biocare S Series Implants | Nobel Biocare Services AG |
| 2 Feb 2026 | K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. |
| 8 Jan 2026 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. |
| 23 Dec 2025 | K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC |
| 23 Dec 2025 | K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC |
| 22 Dec 2025 | K251605 | DIMPLO Implant System | DIMPLO Ltd. |
| 12 Dec 2025 | K252090 | Pterygoid Indication for GM Helix Implants | Institut Straumann AG |
| 7 Nov 2025 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.i.n. - Sistema de Implante Nacional S.A. |
| 30 Oct 2025 | K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC |
| 10 Oct 2025 | K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International Inc. |
| 29 Sep 2025 | K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions Inc. |
| 26 Sep 2025 | K251262 | S.I.N. Dental Implant System | S.i.n. - Sistema de Implante Nacional S.A. |
| 25 Sep 2025 | K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl |
| 25 Aug 2025 | K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare Services AG |
| 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. |
| 18 Aug 2025 | K250271 | Neodent Implant System - Zirconia Implant System | Institut Straumann AG |
| 13 Aug 2025 | K251046 | S.I.N. Dental Implant System | S.i.n. - Sistema de Implante Nacional S.A. |
| 12 Aug 2025 | K250294 | Straumann® RidgeFit Implants | Institut Straumann AG |
| 24 Jul 2025 | K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. |
| 23 Jul 2025 | K251280 | DESS® Dental Implants | Terrats Medical, S.L. |
| 23 Jul 2025 | K250280 | SD TL Implant System | ARUM DENTISTRY Co., Ltd |
| 9 Jul 2025 | K243731 | HEXIM Implant; Samwon General Abutments | P&a Usa |
| 3 Jul 2025 | K243255 | URIS Long Implant & Abutments | TruAbutment Inc. |
| 27 Jun 2025 | K251660 | T3 Pro Implants ZimVie Packaging System | Biomet 3i, LLC |
| 18 Jun 2025 | K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems Ltd |
| 6 Jun 2025 | K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. |
| 14 May 2025 | K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL |
| 8 May 2025 | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone |
| 21 Apr 2025 | K250176 | DAND Dental Implant System | d.a.n.d metal industries north LTD |
| 24 Feb 2025 | K241703 | SD Implant System | ARUM DENTISTRY Co., Ltd |
| 11 Feb 2025 | K241462 | LONGY Implant and LONGY-N Implant | Noris Medical Ltd. |
| 29 Jan 2025 | K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments Ltd |
| 8 Jan 2025 | K242661 | TRI-matrix® X-Force Implants | TRI Dental Implants Int. AG |
| 6 Jan 2025 | K242753 | SD TL Implant System | ARUM DENTISTRY Co., Ltd |
| 27 Dec 2024 | K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. |
| 27 Dec 2024 | K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. |
| 20 Dec 2024 | K240435 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH |
| 19 Dec 2024 | K243094 | Quickdent Dental Implant System | Quickdent Devices Private Limited |
| 16 Dec 2024 | K243066 | Dental Implants and Abutments | Ditron Dental Ltd |
| 10 Dec 2024 | K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG |
| 25 Nov 2024 | K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. |
| 15 Nov 2024 | K233081 | NUVENTUS NV.C Dental Implant System | Infinitum Eta Ltd. |
| 7 Nov 2024 | K242379 | LL Implant System | Ossvis Co., Ltd. |
| 6 Nov 2024 | K242261 | Accelx Implant System | Biotech Dental |
| 31 Oct 2024 | K240383 | Highness Implant System | highness Co.,Ltd. |
| 30 Oct 2024 | K240560 | ZENEX Implant System_Long | Izenimplant Co., Ltd. |
| 23 Oct 2024 | K241753 | Immediate Molar Implants | Biomet 3i, LLC |
| 11 Oct 2024 | K240143 | JDZygoma dental implants | Jdentalcare Srl |
| 10 Oct 2024 | K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | B.t.i. Biotechnology |
| 13 Sep 2024 | K240977 | DenQ Sub SLA Implant System | DenQ Co., Ltd. |
| 13 Sep 2024 | K240232 | EK D3.3 and Ultra Wide Implants | Hiossen Inc. |
| 12 Sep 2024 | K240803 | Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC |
| 5 Sep 2024 | K231566 | ICX-Implant System | Medentis Medical GmbH |
| 23 Aug 2024 | K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw | Proimtech Saglik Urunleri Anonim Sirketi |
| 16 Aug 2024 | K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | Jdentalcare Srl |
| 15 Aug 2024 | K240837 | TOV Dental Implant System | RDJ TOV Implant Ltd |
| 31 Jul 2024 | K233808 | LW Narrow Implant System | Ossvis Co., Ltd. |
| 17 Jul 2024 | K240609 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 9 Jul 2024 | K240966 | Prima Plus Conical Implant System | Keystone Dental Inc. |
| 6 Jun 2024 | K240202 | Conical Platform Dental Implants System | Noris Medical Ltd. |
| 5 Jun 2024 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. |
| 31 May 2024 | K232821 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 24 May 2024 | K231426 | 8plant Implant System | Hoowon Edi Co., Ltd. |
| 22 May 2024 | K232740 | Paltop Short Implants | Paltop Advanced Dental Solutions Inc. |
| 20 May 2024 | K240511 | Dentis s-Clean SQ-SL Fixture | Dentis Co., Ltd. |
| 16 May 2024 | K233137 | Ticare Dental Implant Systems | Mozograu S.A. |
| 30 Apr 2024 | K233231 | Dental Implants and Abutments | Ditron Dental Ltd |
| 26 Apr 2024 | K240091 | NB Mini Implant System | ARUM DENTISTRY Co., Ltd |
| 11 Apr 2024 | K221847 | Ni2 Implant System | newton implant systems |
| 1 Apr 2024 | K232726 | External Hex Implant System | Southern Implants, Inc. |
| 28 Mar 2024 | K232049 | IS-III active Short Implant | Neobiotech Co., Ltd. |
| 25 Mar 2024 | K232268 | STERI-OSS Implant System | ZEROS Co., Ltd. |
| 20 Mar 2024 | K234049 | Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG |
| 18 Jan 2024 | K221866 | S-Plant Dental Implant System | newton implant systems |
| 29 Dec 2023 | K230438 | URIS Smart Path Implant System & Prosthetic | TruAbutment Inc. |
| 29 Dec 2023 | K223714 | UniFit Dental Implant System | ADIN DENTAL IMPLANT SYSTEMS Ltd |
| 19 Dec 2023 | K233163 | ZENEX Implant System_Short | Izenimplant Co., Ltd. |
| 18 Dec 2023 | K231429 | S-Plant Dental Implant System | IDIS Co. Ltd. |
| 7 Dec 2023 | K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. |
| 7 Dec 2023 | K231127 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 1 Dec 2023 | K232418 | Single Platform SP1 Implant System | Southern Implants, Inc. |
| 31 Oct 2023 | K232099 | Neodent Implant System - GM Zygomatic Implant System | Institut Straumann AG |
| 25 Oct 2023 | K221315 | UNIdental Symphony Implant System | Unidental Co., Ltd. |
| 18 Oct 2023 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. |
| 16 Oct 2023 | K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | Institut Straumann AG |
| 13 Oct 2023 | K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | BioHorizons Implant Systems, Inc. |
| 11 Oct 2023 | K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. |
| 5 Oct 2023 | K230242 | OsteoCentric Dental Implant System | OsteoCentric Technologies Inc |
| 23 Sep 2023 | K222778 | Osstem Implant System | Osstem Implant Co., Ltd. |
| 14 Sep 2023 | K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG |
| 23 Aug 2023 | K222946 | Oneday Mini Implant System | Oneday Biotech Co., Ltd. |
| 8 Aug 2023 | K223924 | LW Implant System | Ossvis Co., Ltd. |
| 31 Jul 2023 | K230630 | ZENEX Implant System_Narrow | Izenimplant Co., Ltd. |
| 18 Jul 2023 | K223339 | Bone Chamber Implant | Megagen Implant Co., Ltd. |
| 7 Jul 2023 | K222707 | IH Implant System | Sewon Medix, Inc. |
| 1 Jul 2023 | K230725 | NB Implant System | ARUM DENTISTRY Co., Ltd |
| 26 Jun 2023 | K221488 | Z7 Zirconia Implant System | Z7 LLC |
| 24 Jun 2023 | K222142 | BR SLA Type Implant System | Biotem Co., Ltd. |
| 23 Jun 2023 | K223638 | Neodent Implant System - Helix Short Implant System | Institut Straumann AG |
| 22 Jun 2023 | K223083 | Straumann SLActive labeling changes | Institut Straumann AG |
| 14 Jun 2023 | K222144 | IR SLA Type Implant System | Biotem Co., Ltd. |
| 8 Jun 2023 | K222792 | SNUCONE Tissue Level Implant System | SNUCONE Co., LTD. |
| 4 Jun 2023 | K221752 | Stella | Shinhung Mst Co., Ltd. |
| 25 May 2023 | K223814 | Genesis ACTIVE Implant System | Keystone Dental Inc. |
| 13 Apr 2023 | K222738 | Point implant system | Pointnix Co., Ltd. |
| 6 Mar 2023 | K222457 | Provata Implant System | Southern Implants, Inc. |
| 2 Feb 2023 | K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | Implant Direct |
| 13 Jan 2023 | K221317 | S-Mono | Shinhung Mst Co., Ltd. |
| 6 Jan 2023 | K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | Megagen Implant Co., Ltd. |
| 20 Dec 2022 | K220517 | IBS System | InnoBioSurg Co.,Ltd |
| 20 Dec 2022 | K213677 | Bonafix 2 Plus | Zentek Medical LLC |
| 15 Dec 2022 | K221453 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 14 Dec 2022 | K221910 | QRS Dental Implants System | Qrs Medical , Ltd. |
| 14 Dec 2022 | K220079 | Magicore Narrow System | InnoBioSurg Co.,Ltd |
| 16 Nov 2022 | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona, Inc. |
| 16 Nov 2022 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | Dentsply Sirona, Inc. |
| 9 Nov 2022 | K222497 | Zaga Zygomatic System | Southern Implants, Inc. |
| 27 Oct 2022 | K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 19 Oct 2022 | K211409 | Proximerge 2 Dental Implant System | Quadric Biomed, LLC |
| 13 Oct 2022 | K212702 | IM/ST Fixture System | Guilin Fiteeth Medical Instrument Co., Ltd. |
| 19 Sep 2022 | K222131 | NB 1 SA Implant System | ARUM DENTISTRY Co., Ltd |
| 14 Sep 2022 | K220978 | TSX Implants | Biomet 3i, LLC |
| 6 Sep 2022 | K220251 | Neodent Implant System - GM Narrow Implant System | Institut Straumann AG |
| 10 Aug 2022 | K212364 | BLT Dental Implant System | BIO CONCEPT Co., Ltd |
| 21 Jul 2022 | K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.t.i. Biotechnology |
| 15 Jul 2022 | K213997 | Kontact Dental Implant System | Biotech Dental |
| 15 Jul 2022 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical |
| 13 Jul 2022 | K210354 | SNUCONE Bone Level Implant System | SNUCONE Co., LTD. |
| 8 Jul 2022 | K212775 | Adin Short Implants | Adin Dental Implants Systems , Ltd. |
| 30 Jun 2022 | K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | Blue Sky Bio, LLC |
| 24 Jun 2022 | K210852 | Noris Medical Dental Implants System - Cortical | Noris Medical Ltd. |
| 25 May 2022 | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions Inc. |
| 13 Apr 2022 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. |
| 6 Apr 2022 | K213506 | NB 1 SA Implant System | ARUM DENTISTRY Co., Ltd |
| 4 Apr 2022 | K220022 | TRATE Dental Implant System | Roott LLC |
| 28 Mar 2022 | K213672 | T3 Pro Implants | Biomet 3i, LLC |
| 17 Mar 2022 | K210489 | SICtapered & SICvantage tapered | SIC invent AG |
| 1 Mar 2022 | K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | KJ Meditech Co., Ltd. |
| 23 Feb 2022 | K213599 | SuperLine | Dentium USA |
| 28 Jan 2022 | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | Institut Straumann AG |
| 7 Jan 2022 | K210039 | CORE1 Implant System | Cybermed Inc. |
| 7 Jan 2022 | K203360 | EK Implants and Abutments System | Hiossen Inc. |
| 5 Jan 2022 | K211978 | Jplant | Jj Medical Co., Ltd. |
| 21 Dec 2021 | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG |
| 21 Dec 2021 | K203660 | TRI-matrix Implant Line | TRI Dental Implants Int. AG |
| 14 Dec 2021 | K212538 | DESS Dental Implants | Terrats Medical, S.L. |
| 30 Nov 2021 | K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions Inc. |
| 1 Nov 2021 | K210499 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH |
| 20 Oct 2021 | K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 15 Oct 2021 | K212517 | Magicore System | InnoBioSurg Co.,Ltd |
| 30 Sep 2021 | K210523 | Implanova | Dental Evolutions, Inc. |
| 24 Sep 2021 | K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | Nobel Biocare Services AG |
| 23 Sep 2021 | K202092 | ABC Dental Implant System | Abracadabra Implants Ltd. |
| 28 Aug 2021 | K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. |
| 27 Aug 2021 | K210610 | PrimeTaper EV Dental Implant | Dentsply Sirona, Inc. |
| 13 Aug 2021 | K210336 | Neodent Implant System - Zirconia Implant System | Institut Straumann AG |
| 29 Jul 2021 | K202825 | BTI Extra-Short Dental Implant System UnicCa | B.t.i. Biotechnology |
| 8 Jul 2021 | K211052 | Straumann RidgeFit Implants | Institut Straumann AG |
| 6 Jul 2021 | K203309 | NUVO CF Implant System | Institut Straumann AG |
| 23 Jun 2021 | K203725 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 22 Jun 2021 | K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. |
| 21 Jun 2021 | K210855 | Straumann BLX Implant System | Institut Straumann AG |
| 18 Jun 2021 | K210220 | Kontact Dental Implant System | Biotech Dental |
| 17 Jun 2021 | K210886 | MIS Lance+ Conical Connection Dental Implant System | Dentsply Sirona, Inc. |
| 4 Jun 2021 | K210080 | Dentis s-Clean s-Line Mini | Dentis Co., Ltd. |
| 26 May 2021 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda |
| 14 May 2021 | K200573 | BoneTrust Mini Implant System | Medical Instinct Deutschland GmbH |
| 22 Apr 2021 | K200329 | IDCAM Dental Implants | Implants Diffusion International |
| 19 Apr 2021 | K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. |
| 15 Apr 2021 | K203701 | Locator Overdenture Implant System | Ivory Super Holdco Inc. / Zest Anchors, LLC |
| 18 Mar 2021 | K202773 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. |
| 15 Mar 2021 | K203382 | Neodent Implant System-Easy Pack | Institut Straumann AG |
| 17 Feb 2021 | K210132 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. |
| 11 Feb 2021 | K192839 | DSP Implant System | D.S.P Industrial Eireli |
| 8 Feb 2021 | K202942 | Straumann 4 mm Short Implants | Institut Straumann AG |
| 22 Jan 2021 | K201553 | Simply Iconic Implants | Implant Direct |
| 13 Jan 2021 | K201700 | BEGO Semados® RS/RSX Implant System | BEGO Implant Systems GmbH & Co. KG |
| 22 Dec 2020 | K201491 | Neodent Implant System - Zirconia Implant System | Institut Straumann AG |
| 1 Dec 2020 | K201712 | Z5-TL | Z-Systems AG |
| 17 Nov 2020 | K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. |
| 16 Nov 2020 | K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare Services AG |
| 10 Nov 2020 | K183044 | JTK Dental Implant System | Jiangyin Jintech Biotech Co., Ltd. |
| 20 Oct 2020 | K181477 | MS Lide Implant Systems | Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. |
| 16 Oct 2020 | K200906 | MINICONE Implant | Institut Straumann AG |
| 14 Oct 2020 | K200386 | Z5-BL | Z-Systems AG |
| 7 Oct 2020 | K200817 | URIS OMNI Narrow System & Prosthetic | TruAbutment Inc. |
| 29 Sep 2020 | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | CAMLOG Biotechnologies GmbH |
| 25 Sep 2020 | K202039 | Honorst Implant System | Medimecca Co., Ltd. |
Showing the 200 most recent of 1,550.
Official records: FDA product classification for DZE · 21 CFR 872.3640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026