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 1 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2026-09-30 | Traditional | PDF ↗ |
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | 2026-09-23 | Traditional | PDF ↗ |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | 2026-09-21 | Special | PDF ↗ |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | 2026-08-06 | Traditional | PDF ↗ |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 | Traditional | PDF ↗ |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | 2026-06-27 | Traditional | PDF ↗ |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026-06-26 | Traditional | PDF ↗ |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 | Traditional | PDF ↗ |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | 2026-06-11 | Abbreviated | PDF ↗ |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-06-09 | Traditional | PDF ↗ |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026-06-03 | Traditional | PDF ↗ |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | 2026-05-20 | Traditional | PDF ↗ |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026-05-14 | Traditional | PDF ↗ |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026-05-07 | Traditional | PDF ↗ |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-04-16 | Traditional | PDF ↗ |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2026-04-09 | Special | PDF ↗ |
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 | Traditional | PDF ↗ |
| K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | 2026-02-10 | Traditional | PDF ↗ |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 | Traditional | PDF ↗ |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 2026-01-29 | Traditional | PDF ↗ |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 | Traditional | PDF ↗ |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026-01-22 | Traditional | PDF ↗ |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 | Traditional | PDF ↗ |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 | Traditional | PDF ↗ |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 | Traditional | PDF ↗ |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025-12-18 | Traditional | PDF ↗ |
| K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025-12-09 | Traditional | PDF ↗ |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025-11-26 | Traditional | PDF ↗ |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona | 2025-11-21 | Traditional | PDF ↗ |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K251547 | DESS Dental Smart Solutions | Terrats Medical SL | 2025-10-31 | Traditional | PDF ↗ |
| K252384 | DESS® Dental Smart Solutions | Terrats Medical SL | 2025-10-23 | Traditional | PDF ↗ |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-10-17 | Traditional | PDF ↗ |
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems , Ltd. | 2025-10-17 | Traditional | PDF ↗ |
| K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2025-10-16 | Traditional | PDF ↗ |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025-10-15 | Special | PDF ↗ |
| K251294 | Bonafix Implant Abutments | Zentek Medical, LLC | 2025-10-15 | Traditional | PDF ↗ |
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | 2025-09-16 | Traditional | PDF ↗ |
| K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | 2025-09-02 | Abbreviated | PDF ↗ |
| K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025-08-20 | Traditional | PDF ↗ |
| K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2025-08-20 | Traditional | PDF ↗ |
| K251220 | NUVENTUS NV.C Prosthetic Components | Infinitum Eta, Ltd. | 2025-07-28 | Traditional | PDF ↗ |
| K241183 | ISO Abutment | Seum Medi Co., Ltd. | 2025-07-28 | Traditional | PDF ↗ |
| K250967 | Sherlock | Open Implants, LLC | 2025-06-26 | Traditional | PDF ↗ |
| K243009 | MIST IC | Imagine Milling Technologies, LLC | 2025-06-24 | Traditional | PDF ↗ |
| K242978 | Geo Abutment | Geomedi Co,., Ltd. | 2025-06-16 | Traditional | PDF ↗ |
| K243530 | Dynamic TiBase | Talladium España, SL | 2025-05-30 | Traditional | PDF ↗ |
| K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2025-05-27 | Traditional | PDF ↗ |
| K250639 | DESS Dental Smart Solutions | Terrats Medical SL | 2025-05-22 | Traditional | PDF ↗ |
| K243824 | Preat Abutments | Preat Corporation | 2025-05-08 | Traditional | PDF ↗ |
| K243521 | Conical Ti Base abutments | BioHorizons Implant Systems, Inc. | 2025-05-01 | Traditional | PDF ↗ |
| K250295 | Dentsply Sirona Titanium Bases system | Dentsply Sirona | 2025-04-30 | Traditional | PDF ↗ |
| K242542 | Medentika CAD/CAM Abutments | Medentika GmbH | 2025-04-22 | Traditional | PDF ↗ |
| K250081 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025-04-11 | Traditional | PDF ↗ |
| K232383 | iPhysio® System | Euroteknika | 2025-03-04 | Traditional | PDF ↗ |
| K243278 | Custom Abutments | Institut Straumann AG | 2025-02-21 | Traditional | PDF ↗ |
| K243478 | Straumann InLab Validated Workflow | Institut Straumann AG | 2025-02-19 | Traditional | PDF ↗ |
| K243212 | DESS Dental Smart Solutions | Terrats Medical SL | 2025-02-14 | Traditional | PDF ↗ |
| K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | 2025-01-17 | Abbreviated | PDF ↗ |
| K243272 | LOCATOR Angled Abutment | Zest Anchors, LLC | 2025-01-14 | Traditional | PDF ↗ |
| K242030 | MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. | 2025-01-13 | Traditional | PDF ↗ |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Hiossen, Inc. | 2025-01-08 | Abbreviated | PDF ↗ |
| K240346 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | 2025-01-03 | Traditional | PDF ↗ |
| K242819 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2024-12-19 | Traditional | PDF ↗ |
| K241616 | ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. | 2024-12-17 | Traditional | PDF ↗ |
| K242025 | Elos Accurate® Hybrid Base | Elos Medtech Pinol A/S | 2024-12-10 | Traditional | PDF ↗ |
| K242703 | LW Pre-milled Abutment | Ossvis Co., Ltd. | 2024-12-05 | Traditional | PDF ↗ |
| K242686 | Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2024-12-04 | Traditional | PDF ↗ |
| K242245 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024-11-25 | Traditional | PDF ↗ |
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | Straumann USA, LLC | 2024-11-11 | Traditional | PDF ↗ |
| K242340 | DESS Dental Smart Solutions | Terrats Medical SL | 2024-11-05 | Traditional | PDF ↗ |
| K241170 | Dynamic TiBase; TRI Screws | Talladium España, SL | 2024-10-21 | Traditional | PDF ↗ |
| K240725 | PreXolid CAD/CAM abutments | Eclectic Co., Ltd. | 2024-10-18 | Traditional | PDF ↗ |
| K241485 | TruAbutment DS; TruBase | Truabutment, Inc. | 2024-10-09 | Traditional | PDF ↗ |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2024-09-18 | Traditional | PDF ↗ |
| K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | 2024-09-13 | Traditional | PDF ↗ |
| K240982 | DESS Dental Smart Solutions | Terrats Medical SL | 2024-08-26 | Traditional | PDF ↗ |
| K231932 | TDS (TECHWIN DENTAL SYSTEM) | Techwin Co., Ltd. | 2024-08-20 | Traditional | PDF ↗ |
| K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | BioHorizons Implant Systems, Inc. | 2024-07-30 | Traditional | PDF ↗ |
| K241063 | s-Clean ScanHealing Abutment | Dentis Co., Ltd. | 2024-07-25 | Traditional | PDF ↗ |
| K241032 | BellaTek Bars | Biomet 3i, LLC | 2024-07-15 | Traditional | PDF ↗ |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | Prismatik Dentalcraft, Inc. | 2024-07-12 | Traditional | PDF ↗ |
| K240570 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2024-06-07 | Traditional | PDF ↗ |
| K240603 | Ti-Base & Master Fix | Arum Dentistry Co., Ltd. | 2024-06-05 | Traditional | PDF ↗ |
| K233587 | LOCATOR Angled Abutment (Various) | Zest Anchors, LLC | 2024-06-03 | Traditional | PDF ↗ |
| K233389 | EK Digital Abutments | Hiossen, Inc. | 2024-05-29 | Traditional | PDF ↗ |
| K233285 | KATANA Zirconia ONE For IMPLANT | Kuraray Noritake Dental, Inc. | 2024-05-24 | Traditional | PDF ↗ |
| K231940 | BruxZir® NOW SRC | Prismatik Dentalcraft, Inc. | 2024-05-15 | Traditional | PDF ↗ |
| K234112 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024-05-09 | Traditional | PDF ↗ |
| K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | Dentsply Sirona | 2024-05-07 | Traditional | PDF ↗ |
| K233857 | Neodent Implant System Custom Abutments | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-05-02 | Traditional | PDF ↗ |
| K232528 | Protective Cap | Neobiotech Co., Ltd. | 2024-04-30 | Traditional | PDF ↗ |
| K240208 | DESS Dental Smart Solutions | Terrats Medical SL | 2024-04-24 | Traditional | PDF ↗ |
| K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | Medentika GmbH | 2024-04-15 | Traditional | PDF ↗ |
| K231132 | J & P Click Attachments | J & P Dental Technologies | 2024-03-26 | Traditional | PDF ↗ |
| K233167 | LW Implant System Abutment | Ossvis Co., Ltd. | 2024-03-25 | Traditional | PDF ↗ |
| K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2024-03-09 | Traditional | PDF ↗ |
| K231210 | DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. | 2024-03-05 | Traditional | PDF ↗ |
| K231915 | Zfx Abutments | Zfx GmbH - A Company of Zimvie | 2024-03-01 | Traditional | PDF ↗ |
| K231753 | Oneday Implant Abutment | Oneday Biotech Co., Ltd. | 2024-02-21 | Traditional | PDF ↗ |
Product code NHA · Class II · Dental. Data: openFDA.