FDA Product Code
FDA Product Code NHA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3630
510(k) Clearances — 716 records · page 2 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233194 | TS Abutment System | Osstem Implant Co., Ltd. | 2024-02-20 | Traditional | PDF ↗ |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | Nobel Biocare AB | 2024-01-24 | Traditional | PDF ↗ |
| K233450 | MegaGen 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 Screw | Megagen Implant Co., Ltd. | 2024-01-22 | Traditional | PDF ↗ |
| K232170 | Ti Link Abutment | Izenimplant Co., Ltd. | 2024-01-12 | Traditional | PDF ↗ |
| K233316 | DESS Dental Smart Solutions | Terrats Medical SL | 2024-01-05 | Traditional | PDF ↗ |
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | Anthogyr | 2024-01-04 | Traditional | PDF ↗ |
| K231307 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2023-12-21 | Traditional | PDF ↗ |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K232560 | Angled Abutment | Arum Dentistry Co., Ltd. | 2023-12-19 | Traditional | PDF ↗ |
| K231803 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-12-13 | Traditional | PDF ↗ |
| K232750 | BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2023-12-08 | Traditional | PDF ↗ |
| K232220 | SS Abutment System | Osstem Implant Co., Ltd. | 2023-12-05 | Traditional | PDF ↗ |
| K232546 | Meta G UCLA Abutment | Cowellmedi Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K231559 | Multi-Unit DAS System | Talladium España, SL | 2023-11-17 | Traditional | PDF ↗ |
| K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | Prismatik Dentalcraft, Inc. | 2023-11-14 | Traditional | PDF ↗ |
| K231874 | AOT & T-L Abutment | Truabutment, Inc. | 2023-10-30 | Traditional | PDF ↗ |
| K232271 | SIMDA abutment | Simda Co., Ltd. | 2023-10-26 | Traditional | PDF ↗ |
| K232151 | Dynamic TiBase | Talladium España, SL | 2023-10-17 | Traditional | PDF ↗ |
| K231413 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2023-10-10 | Traditional | PDF ↗ |
| K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | 2023-10-02 | Traditional | PDF ↗ |
| K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | Prismatik Dentalcraft, Inc. | 2023-09-26 | Traditional | PDF ↗ |
| K231235 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-09-15 | Traditional | PDF ↗ |
| K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | 2023-09-15 | Traditional | PDF ↗ |
| K231079 | LW Retraction Cap | Ossvis Co., Ltd. | 2023-09-14 | Traditional | PDF ↗ |
| K230317 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2023-09-01 | Traditional | PDF ↗ |
| K231557 | ZENEX FreeMilling & CCM Cast Abutment | Izenimplant Co., Ltd. | 2023-08-24 | Traditional | PDF ↗ |
| K220253 | Eco Abutment, Multiunit Abutment | Dio Corporation | 2023-08-18 | Traditional | PDF ↗ |
| K231455 | Implant-One System | Implant Logistics, Inc. | 2023-08-15 | Traditional | PDF ↗ |
| K231434 | DESS Dental Smart Solutions | Terrats Medical SL | 2023-08-14 | Traditional | PDF ↗ |
| K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023-08-04 | Traditional | PDF ↗ |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. | 2023-08-01 | Traditional | PDF ↗ |
| K221673 | Bonafix TiBase | Zentek Medical, LLC | 2023-07-14 | Traditional | PDF ↗ |
| K222026 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-07-14 | Traditional | PDF ↗ |
| K230307 | Dentis i-Clean System | Dentis Co., Ltd. | 2023-07-11 | Traditional | PDF ↗ |
| K223535 | SMARTbase Abutment System | Implant Direct Sybron Manufacturing, LLC | 2023-06-20 | Traditional | PDF ↗ |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | Dentis Co., Ltd. | 2023-05-25 | Traditional | PDF ↗ |
| K230523 | s-Clean Link Abutment Narrow | Dentis Co., Ltd. | 2023-05-24 | Traditional | PDF ↗ |
| K223663 | SIMDA Abutment | Simda Co., Ltd. | 2023-05-24 | Traditional | PDF ↗ |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Institut Straumann AG | 2023-05-15 | Traditional | PDF ↗ |
| K221969 | IU Implant System Abutment | Warantec Co., Ltd. | 2023-05-12 | Traditional | PDF ↗ |
| K230203 | Dentis I-FIX Abutment | Dentis Co., Ltd. | 2023-05-03 | Traditional | PDF ↗ |
| K223634 | Customized Abutment | Arum Dentistry Co., Ltd. | 2023-04-28 | Traditional | PDF ↗ |
| K222636 | ET Abutment System | Hiossen, Inc. | 2023-04-28 | Traditional | PDF ↗ |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | Nobel Biocare AB | 2023-04-28 | Traditional | PDF ↗ |
| K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | Dental Direkt GmbH | 2023-04-25 | Traditional | PDF ↗ |
| K230103 | Klockner Abutments | SOADCO, S.L. | 2023-04-24 | Traditional | PDF ↗ |
| K222469 | TIB Abutments | Southern Implants (Pty), Ltd. | 2023-04-17 | Traditional | PDF ↗ |
| K230143 | DESS Dental Smart Solutions | Terrats Medical SL | 2023-04-13 | Traditional | PDF ↗ |
| K230069 | S.I.N. Dental Implant System | S.I.N. Sistema DE Implante Nacional S.A. | 2023-04-06 | Traditional | PDF ↗ |
| K212394 | Implant-One Multi-Unit Abutment | Implant Logistics, Inc. | 2023-03-23 | Traditional | PDF ↗ |
| K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Dentsply Sirona, Inc. | 2023-03-22 | Traditional | PDF ↗ |
| K221301 | DESS Dental Smart Solutions | Terrats Medical SL | 2023-03-09 | Traditional | PDF ↗ |
| K222451 | SAVE GBR | Dentis Co., Ltd. | 2023-02-07 | Traditional | PDF ↗ |
| K223395 | Luna Dental Implant System | Shinhung Mst Co., Ltd. | 2023-02-03 | Traditional | PDF ↗ |
| K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023-01-13 | Traditional | PDF ↗ |
| K222976 | MU System | Dentis Co., Ltd. | 2023-01-12 | Traditional | PDF ↗ |
| K191111 | DD Solid Connect® CAD/CAM Abutments | Dental Direkt GmbH | 2023-01-11 | Traditional | PDF ↗ |
| K222984 | BioClean Implant Restorative System | Bioclean Dental, LLC | 2022-12-29 | Traditional | PDF ↗ |
| K220390 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2022-12-02 | Traditional | PDF ↗ |
| K222368 | MIST IC | Imagine Milling Technologies, LLC | 2022-12-01 | Traditional | PDF ↗ |
| K222044 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2022-11-30 | Traditional | PDF ↗ |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022-11-10 | Traditional | PDF ↗ |
| K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022-10-27 | Traditional | PDF ↗ |
| K222269 | DESS Dental Smart Solutions | Terrats Medical SL | 2022-10-26 | Traditional | PDF ↗ |
| K220823 | Preat Abutments | Preat Corporation | 2022-10-26 | Traditional | PDF ↗ |
| K222215 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2022-10-21 | Traditional | PDF ↗ |
| K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2022-10-20 | Traditional | PDF ↗ |
| K202144 | A.B. Dental Devices Dental Implants System | A.B. Dental Device , Ltd. | 2022-09-23 | Traditional | PDF ↗ |
| K220339 | Esthetic Abutments Nobel Biocare N1 | Nobel Biocare Services AG | 2022-09-16 | Traditional | PDF ↗ |
| K221966 | Dynamic TiBase | Talladium Espana, SL | 2022-09-15 | Traditional | PDF ↗ |
| K221684 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2022-09-08 | Traditional | PDF ↗ |
| K221381 | KDG Abutments | Keystone Dental, Inc. | 2022-08-10 | Traditional | PDF ↗ |
| K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022-07-29 | Traditional | PDF ↗ |
| K213961 | TruAbutment DS, TruBase | Truabutment, Inc. | 2022-07-14 | Traditional | PDF ↗ |
| K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2022-07-05 | Traditional | PDF ↗ |
| K220482 | Sherlock | Open Implants, LLC | 2022-06-21 | Traditional | PDF ↗ |
| K220440 | Dentis s-Clean Abutment Mini | Dentis Co., Ltd. | 2022-06-16 | Traditional | PDF ↗ |
| K220878 | Straumann TLX Variobase C | Institut Straumann AG | 2022-06-16 | Traditional | PDF ↗ |
| K220612 | PrimeLOC Attachment System | Innovative Product Brands, Inc. | 2022-06-06 | Traditional | PDF ↗ |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG | 2022-06-02 | Traditional | PDF ↗ |
| K211396 | Neoss Individual Prosthetics | Neoss, Ltd. | 2022-05-17 | Traditional | PDF ↗ |
| K220252 | High Retention Attachment System | Zest Anchors, LLC | 2022-04-14 | Special | PDF ↗ |
| K213063 | TLX SRAs and TLX Gold Abutments | Institut Straumann AG | 2022-04-08 | Traditional | PDF ↗ |
| K213432 | MIS Angulated multi-unit abutments | Dentsply Sirona | 2022-04-01 | Traditional | PDF ↗ |
| K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022-03-11 | Traditional | PDF ↗ |
| K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | 2022-03-03 | Traditional | PDF ↗ |
| K210356 | Noris Medical Dental Implants System | Noris Medical , Ltd. | 2022-02-04 | Traditional | PDF ↗ |
| K210826 | Healing Abutment, Cover Screw | Megagen Implant Co., Ltd. | 2022-02-03 | Traditional | PDF ↗ |
| K201323 | INNO SLA Submerged Implant System | Cowellmedi Co., Ltd. | 2022-01-25 | Traditional | PDF ↗ |
| K213391 | High Retention Attachment System | Zest Anchors, LLC | 2022-01-11 | Traditional | PDF ↗ |
| K212730 | BellaTek Encode Emergence Healing Abutments | Biomet 3i, LLC | 2021-12-21 | Special | PDF ↗ |
| K212577 | DESS Dental Smart Solutions | Terrats Medical SL | 2021-12-10 | Traditional | PDF ↗ |
| K212664 | Sherlock | Open Implants, LLC | 2021-11-30 | Traditional | PDF ↗ |
| K211871 | FAICO Dental Implant System and CAD/CAM Abutments | Faico Medical, LLC | 2021-11-18 | Traditional | PDF ↗ |
| K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021-11-15 | Special | PDF ↗ |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | Megagen Implant Co., Ltd. | 2021-10-20 | Traditional | PDF ↗ |
| K203750 | Straumann CARES P-Series CAD/CAM System | Institut Straumann AG | 2021-10-09 | Traditional | PDF ↗ |
| K212108 | Dynamic TiBase | Talladium España, SL | 2021-09-24 | Traditional | PDF ↗ |
| K203649 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021-09-15 | Traditional | PDF ↗ |
| K210410 | s-Clean Pre-Milled Abutment Mini | Dentis Co., Ltd. | 2021-09-10 | Traditional | PDF ↗ |
Product code NHA · Class II · Dental. Data: openFDA.