NHA

Abutment, Implant, Dental, Endosseous

Product code
NHA
Device name
Abutment, Implant, Dental, Endosseous
Device class
Class 2
21 CFR
21 CFR 872.3630
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
121
Summaries archived here
106 (direct download)
510(k) clearances (all years, FDA)
713 (all years; only the last 3 years are listed here)

FDA classification definition

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (121)

Last three years. Most recent: 2026-08-06.

NumberDecision dateApplicantDevice nameSummary
K2539992026-08-06Nobel Biocare ABUniversal Base ASC Engaging; Universal Base ASC Non-…PDF
K2611472026-07-01JJGC Indústria e Comércio de Materiais…Neodent Implant System - NeoConvert FitPDF
K2611222026-06-27Imagine Milling Technologies, LLCMIST ICPDF
K2600612026-06-26BioHorizons Implant Systems, Inc.BioHorizons CEREC Compatible Ti-BasesFDA
K2539222026-06-15JJGC Indústria e Comércio de Materiais…Neodent Scannable Healing AbutmentFDA
K2541452026-06-11Smart Denture Conversions, LLCOmni-Directional Multi-Unit Abutment System (Trade N…FDA
K2605642026-06-09Terrats Medical SLDESS Dental Smart SolutionsPDF
K2529042026-06-03Sic Invent AGSIC Abutments including CAD/CAM SolutionsPDF
K2537742026-05-20Elos Medtech Pinol A/SElos Accurate® Denture Fixation SystemFDA
K2533722026-05-14Hiossen, Inc.ET Healing Abutments; ET Scan Healing Abutments; EK …PDF
K2604602026-05-07Institut Straumann AGNeodent Gold Hue Custom Abutments, Medentika Custom …FDA
K2538042026-04-16Terrats Medical SLDESS Dental Smart SolutionsPDF
K2605552026-04-09Zest Anchors, LLCLOCATOR® Angled AbutmentPDF
K2514342026-03-04Osstem Implant Co., Ltd.Healing Abutment SystemPDF
K2515152026-02-10CreoDent Hudson ValleySolidex® Ti-Links and ScrewsPDF
K2514272026-01-29Hiossen, Inc.EK MULTI ANGLED 30 ABUTMENTPDF
K2437322026-01-29Talladium España, SLMulti-Unit DAS SystemPDF
K2533152026-01-22Institut Straumann AGStraumann Variobase Abutments XC for Bridge/BarPDF
K2532532026-01-22Implant Protesis Dental 2004, S.L.IPDmilled BlanksPDF
K2527272026-01-07JJGC Indústria e Comércio de Materiais…Neodent InLab Validated WorkflowPDF
K2533412025-12-23Medentika GmbHCustom Abutments ASPDF
K2533122025-12-23Orangecad Med GmbHOrangeCAD Med AbutmentsPDF
K2523202025-12-18Simda Co., Ltd.SIMDA AbutmentsPDF
K2523432025-12-09Dentsply SironaAtlantis® Abutments in TitaniumFDA
K2522482025-11-26Dentsply SironaCEREC Tessera Abutment SystemPDF
K2512052025-11-21Dentsply SironaAtlantis® Abutments in Titanium for Straumann BLX an…PDF
K2525822025-11-18Prismatik Dentalcraft, Inc.Inclusive® Titanium Abutments compatible with: Camlo…PDF
K2515472025-10-31Terrats Medical SLDESS Dental Smart SolutionsPDF
K2523842025-10-23Terrats Medical SLDESS® Dental Smart SolutionsPDF
K2501782025-10-17Adin Dental Implant Systems , Ltd.Adin Customized AbutmentsPDF
K2522662025-10-17S.I.N. Implant System LtdaS.I.N. Dental Implant SystemPDF
K2514972025-10-16Elos Medtech Pinol A/SElos Accurate Hybrid BasePDF
K2529442025-10-15Zest Anchors, LLCLOCATOR® Angled AbutmentPDF
K2512942025-10-15Zentek Medical, LLCBonafix Implant AbutmentsFDA
K2422872025-09-16Cowellmedi Co., Ltd.SFIT AbutmentFDA
K2427682025-09-02Chengdu Besmile Medical Technology Co.…Customized Abutment and ScrewPDF
K2507212025-08-20Zest Anchors, LLCLOCATOR® Angled AbutmentPDF
K2514712025-08-20Implant Protesis Dental 2004, S.L.IPD Dental Implant AbutmentsPDF
K2512202025-07-28Infinitum Eta, Ltd.NUVENTUS NV.C™ Prosthetic ComponentsPDF
K2411832025-07-28Seum Medi Co., Ltd.ISO AbutmentPDF
K2509672025-06-26Open Implants, LLCSherlockPDF
K2430092025-06-24Imagine Milling Technologies, LLCMIST ICFDA
K2429782025-06-16Geomedi Co,., Ltd.Geo AbutmentPDF
K2435302025-05-30Talladium España, SLDynamic TiBasePDF
K2506142025-05-27Jjgc Indústria E Comércia DE Materiais…Neodent Implant System - Custom AbutmentsPDF
K2506392025-05-22Terrats Medical SLDESS Dental Smart SolutionsPDF
K2438242025-05-08Preat CorporationPreat AbutmentsFDA
K2435212025-05-01BioHorizons Implant Systems, Inc.Conical Ti Base abutmentsPDF
K2502952025-04-30Dentsply SironaDentsply Sirona Titanium Bases systemPDF
K2425422025-04-22Medentika GmbHMedentika CAD/CAM AbutmentsPDF
K2500812025-04-11Dentsply SironaAtlantis® Abutments in TitaniumPDF
K2323832025-03-04EuroteknikaiPhysio® SystemPDF
K2432782025-02-21Institut Straumann AGCustom AbutmentsPDF
K2434782025-02-19Institut Straumann AGStraumann InLab Validated WorkflowPDF
K2432122025-02-14Terrats Medical SLDESS Dental Smart SolutionsPDF
K2420642025-01-17Smart Denture Conversions, LLCOmni-Directional Multi-unit Abutment System (Trade N…FDA
K2432722025-01-14Zest Anchors, LLCLOCATOR Angled AbutmentPDF
K2420302025-01-13Megagen Implant Co., Ltd.MegaGen Dental Implant AbutmentPDF
K2410032025-01-08Hiossen, Inc.HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment …PDF
K2403462025-01-03Nobel Biocare ABNobelProcera Zirconia Implant BridgePDF
K2428192024-12-19Implant Protesis Dental 2004, S.L.IPD Dental Implant AbutmentsPDF
K2416162024-12-17Allonus Tech Co., Ltd.ALLONUS Tech ProstheticsPDF
K2420252024-12-10Elos Medtech Pinol A/SElos Accurate® Hybrid Base™PDF
K2427032024-12-05Ossvis Co., Ltd.LW Pre-milled AbutmentPDF
K2426862024-12-04Jjgc Indústria E Comércia DE Materiais…Neodent Implant SystemPDF
K2422452024-11-25Arum Dentistry Co., Ltd.Customized AbutmentPDF
K2415752024-11-11Straumann USA, LLCStraumann® Anatomic Healing Abutments XC (AHA)PDF
K2423402024-11-05Terrats Medical SLDESS Dental Smart SolutionsPDF
K2411702024-10-21Talladium España, SLDynamic TiBase; TRI ScrewsPDF
K2407252024-10-18Eclectic Co., Ltd.PreXolid CAD/CAM abutmentsFDA
K2414852024-10-09Truabutment, Inc.TruAbutment DS; TruBaseFDA
K2341422024-09-18Megagen Implant Co., Ltd.TiGEN Abutment, PMMA Abutment and Scan Healing Abutm…PDF
K2417222024-09-13Elos Medtech Pinol A/SElos Accurate® Hybrid Base™; Elos Accurate® Customiz…PDF
K2409822024-08-26Terrats Medical SLDESS Dental Smart SolutionsPDF
K2319322024-08-20Techwin Co., Ltd.TDS (TECHWIN DENTAL SYSTEM)PDF
K2405312024-07-30BioHorizons Implant Systems, Inc.SmartShape™ Healing Abutment; Wide Custom Milled Ti…FDA
K2410632024-07-25Dentis Co., Ltd.s-Clean ScanHealing AbutmentFDA
K2410322024-07-15Biomet 3i, LLCBellaTek BarsPDF
K2402402024-07-12Prismatik Dentalcraft, Inc.Inclusive® Titanium Abutments compatible with: Keyst…PDF
K2405702024-06-07Implant Protesis Dental 2004, S.L.IPD Dental Implant AbutmentsPDF
K2406032024-06-05Arum Dentistry Co., Ltd.Ti-Base & Master FixPDF
K2335872024-06-03Zest Anchors, LLCLOCATOR Angled Abutment (Various)PDF
K2333892024-05-29Hiossen, Inc.EK Digital AbutmentsPDF
K2332852024-05-24Kuraray Noritake Dental, Inc.KATANA Zirconia ONE For IMPLANTPDF
K2319402024-05-15Prismatik Dentalcraft, Inc.BruxZir® NOW SRCPDF
K2341122024-05-09Arum Dentistry Co., Ltd.Customized AbutmentPDF
K2340182024-05-07Dentsply SironaCEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ A…PDF
K2338572024-05-02JJGC Indústria e Comércio de Materiais…Neodent Implant System – Custom AbutmentsPDF
K2325282024-04-30Neobiotech Co., Ltd.Protective CapPDF
K2402082024-04-24Terrats Medical SLDESS Dental Smart SolutionsPDF
K2231132024-04-15Medentika GmbHMedentika Abutment System, Medentika CAD/CAM Abutmen…PDF
K2311322024-03-26J & P Dental TechnologiesJ & P Click AttachmentsPDF
K2331672024-03-25Ossvis Co., Ltd.LW Implant System – AbutmentPDF
K2330832024-03-09Implant Solutions Pty Ltd (Aka Osteon …Osteon Precision Milled SuprastructurePDF
K2312102024-03-05Modern Dental Laboratory (Dg) Co., Ltd…DGA AbutmentPDF
K2319152024-03-01Zfx GmbH - A Company of ZimvieZfx AbutmentsPDF
K2317532024-02-21Oneday Biotech Co., Ltd.Oneday Implant AbutmentPDF
K2331942024-02-20Osstem Implant Co., Ltd.TS Abutment SystemPDF
K2332082024-01-24Nobel Biocare ABNobelProcera Titanium ASC Abutment, Omnigrip Clinica…PDF
K2334502024-01-22Megagen Implant Co., Ltd.MegaGen Dental Implant Abutment - Scan Healing Abutm…PDF
K2321702024-01-12Izenimplant Co., Ltd.Ti Link AbutmentPDF
K2333162024-01-05Terrats Medical SLDESS Dental Smart SolutionsPDF
K2310722024-01-04AnthogyrAnthogyr FlexiBase® titanium bases for Axiom® BLPDF
K2313072023-12-21Elos Medtech Pinol A/SElos Accurate Customized AbutmentPDF
K2314112023-12-20Cowellmedi Co., Ltd.INNO SLA Submerged Hybrid Ti-Base SystemPDF
K2325602023-12-19Arum Dentistry Co., Ltd.Angled AbutmentPDF
K2318032023-12-13JJGC Indústria e Comércio de Materiais…Neodent Implant System - Zirconia Implant SystemPDF
K2327502023-12-08B.T.I. Biotechnology Institute, Sl.BTI Interna Prosthetic ComponentsPDF
K2322202023-12-05Osstem Implant Co., Ltd.SS Abutment SystemPDF
K2325462023-11-21Cowellmedi Co., Ltd.Meta G UCLA AbutmentPDF
K2315592023-11-17Talladium España, SLMulti-Unit DAS SystemPDF
K2310972023-11-14Prismatik Dentalcraft, Inc.Inclusive® Titanium Abutments compatible with: Neoss…PDF
K2318742023-10-30Truabutment, Inc.AOT & T-L AbutmentPDF
K2322712023-10-26Simda Co., Ltd.SIMDA abutmentPDF
K2321512023-10-17Talladium España, SLDynamic TiBasePDF
K2314132023-10-10Implant Protesis Dental 2004, S.L.IPD Dental Implant AbutmentsPDF
K2219722023-10-02Warantec Co., Ltd.Warantec Custom AbutmentPDF
K2234962023-09-26Prismatik Dentalcraft, Inc.Inclusive® Titanium Abutments compatible with: Strau…PDF
K2312352023-09-15Ossvis Co., Ltd.LW UCLA AbutmentPDF
K2318272023-09-15B.T.I. Biotechnology Institute, Sl.BTI Dental Implant System UnicCa® – Aesthetic Post A…PDF
K2310792023-09-14Ossvis Co., Ltd.LW Retraction CapPDF

106 summaries are archived here for direct download.

Official FDA classification page: NHA
Classification and pathway per current FDA publications. Data from openFDA (CC0).