Abutment, Implant, Dental, Endosseous
Regulation 872.3630
30510(k)s in 12 months (716 all time)
5recalls in 12 months (225 all time)
194recalls that name a 510(k)
Top companies in NHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet 3i | 19 | 174 |
| Nobel Biocare AB | 49 | 7 |
| Institut Straumann AG | 47 | 0 |
| Straumann USA | 32 | 7 |
| Dentsply Sirona | 23 | 0 |
| Terrats Medical SL | 21 | 0 |
| Zimmer Dental, Inc. | 21 | 0 |
| Prismatik Dentalcraft, Inc. | 19 | 1 |
| Osstem Implant Co., Ltd. | 18 | 0 |
| Atlantis Components, Inc. | 17 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2025 | K243521 | Conical Ti Base abutments BioHorizons Implant Systems, Inc. | NHA |
| Apr 30, 2025 | K250295 | Dentsply Sirona Titanium Bases system Dentsply Sirona | NHA |
| Apr 22, 2025 | K242542 | Medentika CAD/CAM Abutments Medentika GmbH, DE | NHA |
| Apr 11, 2025 | K250081 | Atlantis® Abutments in Titanium Dentsply Sirona | NHA |
| Mar 4, 2025 | K232383 | iPhysio® System Euroteknika, FR | NHA |
| Feb 21, 2025 | K243278 | Custom Abutments Institut Straumann AG, CH | NHA |
| Feb 19, 2025 | K243478 | Straumann InLab Validated Workflow Institut Straumann AG, CH | NHA |
| Feb 14, 2025 | K243212 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Jan 17, 2025 | K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut) Smart Denture Conversions, LLC | NHA |
| Jan 14, 2025 | K243272 | LOCATOR Angled Abutment Zest Anchors, LLC | NHA |
| Jan 13, 2025 | K242030 | MegaGen Dental Implant Abutment Megagen Implant Co., Ltd., KR | NHA |
| Jan 8, 2025 | K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) Hiossen, Inc. | NHA |
| Jan 3, 2025 | K240346 | NobelProcera Zirconia Implant Bridge Nobel Biocare AB, SE | NHA |
| Dec 19, 2024 | K242819 | IPD Dental Implant Abutments Implant Protesis Dental 2004, S.L., ES | NHA |
| Dec 17, 2024 | K241616 | ALLONUS Tech Prosthetics Allonus Tech Co., Ltd., KR | NHA |
| Dec 10, 2024 | K242025 | Elos Accurate® Hybrid Base Elos Medtech Pinol A/S, DK | NHA |
| Dec 5, 2024 | K242703 | LW Pre-milled Abutment Ossvis Co., Ltd., KR | NHA |
| Dec 4, 2024 | K242686 | Neodent Implant System Jjgc Indústria E Comércia DE Materiais Dentários S.A., BR | NHA |
| Nov 25, 2024 | K242245 | Customized Abutment Arum Dentistry Co., Ltd., KR | NHA |
| Nov 11, 2024 | K241575 | Straumann® Anatomic Healing Abutments XC (AHA) Straumann USA, LLC | NHA |
| Nov 5, 2024 | K242340 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Oct 21, 2024 | K241170 | Dynamic TiBase; TRI Screws Talladium España, SL, ES | NHA |
| Oct 18, 2024 | K240725 | PreXolid CAD/CAM abutments Eclectic Co., Ltd., KR | NHA |
| Oct 9, 2024 | K241485 | TruAbutment DS; TruBase Truabutment, Inc. | NHA |
| Sep 18, 2024 | K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment Megagen Implant Co., Ltd., KR | NHA |
| Sep 13, 2024 | K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment Elos Medtech Pinol A/S, DK | NHA |
| Aug 26, 2024 | K240982 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Aug 20, 2024 | K231932 | TDS (TECHWIN DENTAL SYSTEM) Techwin Co., Ltd., KR | NHA |
| Jul 30, 2024 | K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment BioHorizons Implant Systems, Inc. | NHA |
| Jul 25, 2024 | K241063 | s-Clean ScanHealing Abutment Dentis Co., Ltd., KR | NHA |
| Jul 15, 2024 | K241032 | BellaTek Bars Biomet 3i, LLC | NHA |
| Jul 12, 2024 | K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direc Prismatik Dentalcraft, Inc. | NHA |
| Jun 7, 2024 | K240570 | IPD Dental Implant Abutments Implant Protesis Dental 2004, S.L., ES | NHA |
| Jun 5, 2024 | K240603 | Ti-Base & Master Fix Arum Dentistry Co., Ltd., KR | NHA |
| Jun 3, 2024 | K233587 | LOCATOR Angled Abutment (Various) Zest Anchors, LLC | NHA |
| May 29, 2024 | K233389 | EK Digital Abutments Hiossen, Inc. | NHA |
| May 24, 2024 | K233285 | KATANA Zirconia ONE For IMPLANT Kuraray Noritake Dental, Inc., JP | NHA |
| May 15, 2024 | K231940 | BruxZir® NOW SRC Prismatik Dentalcraft, Inc. | NHA |
| May 9, 2024 | K234112 | Customized Abutment Arum Dentistry Co., Ltd., KR | NHA |
| May 7, 2024 | K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System Dentsply Sirona | NHA |
| May 2, 2024 | K233857 | Neodent Implant System Custom Abutments JJGC Indústria e Comércio de Materiais Dentários S.A., BR | NHA |
| Apr 30, 2024 | K232528 | Protective Cap Neobiotech Co., Ltd., KR | NHA |
| Apr 24, 2024 | K240208 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Apr 15, 2024 | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments Medentika GmbH, DE | NHA |
| Mar 26, 2024 | K231132 | J & P Click Attachments J & P Dental Technologies | NHA |
| Mar 25, 2024 | K233167 | LW Implant System Abutment Ossvis Co., Ltd., KR | NHA |
| Mar 9, 2024 | K233083 | Osteon Precision Milled Suprastructure Implant Solutions Pty Ltd (Aka Osteon Medical), AU | NHA |
| Mar 5, 2024 | K231210 | DGA Abutment Modern Dental Laboratory (Dg) Co., Ltd., CN | NHA |
| Mar 1, 2024 | K231915 | Zfx Abutments Zfx GmbH - A Company of Zimvie, DE | NHA |
| Feb 21, 2024 | K231753 | Oneday Implant Abutment Oneday Biotech Co., Ltd., KR | NHA |
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