NHA

Abutment, Implant, Dental, Endosseous

产品代码
NHA
器械名称
Abutment, Implant, Dental, Endosseous
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 872.3630
FDA 专业组
Dental
上市路径
需提交 510(k) 上市前通告
标记
属植入器械
该代码近三年的 510(k)
121 件
其中 Summary 已存档
106 份,可直接下载
FDA 历史累计 510(k)
713 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

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

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(121 件)

数据窗口为最近三年。最新一件:2026-08-06。

510(k) 号批准日期申请人器械名称摘要
K2539992026-08-06Nobel Biocare ABUniversal Base ASC Engaging; Universal Base ASC Non-PDF
K2611472026-07-01JJGC Indústria e Comércio de MateriaisNeodent 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 MateriaisNeodent Scannable Healing AbutmentFDA
K2541452026-06-11Smart Denture Conversions, LLCOmni-Directional Multi-Unit Abutment System (Trade NFDA
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 MateriaisNeodent 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 anPDF
K2525822025-11-18Prismatik Dentalcraft, Inc.Inclusive® Titanium Abutments compatible with: CamloPDF
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 MateriaisNeodent 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 NFDA
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 MateriaisNeodent 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 AbutmPDF
K2417222024-09-13Elos Medtech Pinol A/SElos Accurate® Hybrid Base™; Elos Accurate® CustomizPDF
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 TiFDA
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: KeystPDF
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™ APDF
K2338572024-05-02JJGC Indústria e Comércio de MateriaisNeodent 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 AbutmenPDF
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., LtdDGA 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 ClinicaPDF
K2334502024-01-22Megagen Implant Co., Ltd.MegaGen Dental Implant Abutment - Scan Healing AbutmPDF
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 MateriaisNeodent 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: NeossPDF
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: StrauPDF
K2312352023-09-15Ossvis Co., Ltd.LW UCLA AbutmentPDF
K2318272023-09-15B.T.I. Biotechnology Institute, Sl.BTI Dental Implant System UnicCa® – Aesthetic Post APDF

其中 106 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

另有 1 件未列出。

FDA 官方分类页: NHA
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。