NHA
- 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.
该代码近三年的 510(k)(121 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253999 | 2026-08-06 | Nobel Biocare AB | Universal Base ASC Engaging; Universal Base ASC Non- | |
| K261147 | 2026-07-01 | JJGC Indústria e Comércio de Materiais | Neodent Implant System - NeoConvert Fit | |
| K261122 | 2026-06-27 | Imagine Milling Technologies, LLC | MIST IC | |
| K260061 | 2026-06-26 | BioHorizons Implant Systems, Inc. | BioHorizons CEREC Compatible Ti-Bases | FDA |
| K253922 | 2026-06-15 | JJGC Indústria e Comércio de Materiais | Neodent Scannable Healing Abutment | FDA |
| K254145 | 2026-06-11 | Smart Denture Conversions, LLC | Omni-Directional Multi-Unit Abutment System (Trade N | FDA |
| K260564 | 2026-06-09 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K252904 | 2026-06-03 | Sic Invent AG | SIC Abutments including CAD/CAM Solutions | |
| K253774 | 2026-05-20 | Elos Medtech Pinol A/S | Elos Accurate® Denture Fixation System | FDA |
| K253372 | 2026-05-14 | Hiossen, Inc. | ET Healing Abutments; ET Scan Healing Abutments; EK | |
| K260460 | 2026-05-07 | Institut Straumann AG | Neodent Gold Hue Custom Abutments, Medentika Custom | FDA |
| K253804 | 2026-04-16 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K260555 | 2026-04-09 | Zest Anchors, LLC | LOCATOR® Angled Abutment | |
| K251434 | 2026-03-04 | Osstem Implant Co., Ltd. | Healing Abutment System | |
| K251515 | 2026-02-10 | CreoDent Hudson Valley | Solidex® Ti-Links and Screws | |
| K251427 | 2026-01-29 | Hiossen, Inc. | EK MULTI ANGLED 30 ABUTMENT | |
| K243732 | 2026-01-29 | Talladium España, SL | Multi-Unit DAS System | |
| K253315 | 2026-01-22 | Institut Straumann AG | Straumann Variobase Abutments XC for Bridge/Bar | |
| K253253 | 2026-01-22 | Implant Protesis Dental 2004, S.L. | IPDmilled Blanks | |
| K252727 | 2026-01-07 | JJGC Indústria e Comércio de Materiais | Neodent InLab Validated Workflow | |
| K253341 | 2025-12-23 | Medentika GmbH | Custom Abutments AS | |
| K253312 | 2025-12-23 | Orangecad Med GmbH | OrangeCAD Med Abutments | |
| K252320 | 2025-12-18 | Simda Co., Ltd. | SIMDA Abutments | |
| K252343 | 2025-12-09 | Dentsply Sirona | Atlantis® Abutments in Titanium | FDA |
| K252248 | 2025-11-26 | Dentsply Sirona | CEREC Tessera Abutment System | |
| K251205 | 2025-11-21 | Dentsply Sirona | Atlantis® Abutments in Titanium for Straumann BLX an | |
| K252582 | 2025-11-18 | Prismatik Dentalcraft, Inc. | Inclusive® Titanium Abutments compatible with: Camlo | |
| K251547 | 2025-10-31 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K252384 | 2025-10-23 | Terrats Medical SL | DESS® Dental Smart Solutions | |
| K250178 | 2025-10-17 | Adin Dental Implant Systems , Ltd. | Adin Customized Abutments | |
| K252266 | 2025-10-17 | S.I.N. Implant System Ltda | S.I.N. Dental Implant System | |
| K251497 | 2025-10-16 | Elos Medtech Pinol A/S | Elos Accurate Hybrid Base | |
| K252944 | 2025-10-15 | Zest Anchors, LLC | LOCATOR® Angled Abutment | |
| K251294 | 2025-10-15 | Zentek Medical, LLC | Bonafix Implant Abutments | FDA |
| K242287 | 2025-09-16 | Cowellmedi Co., Ltd. | SFIT Abutment | FDA |
| K242768 | 2025-09-02 | Chengdu Besmile Medical Technology Co. | Customized Abutment and Screw | |
| K250721 | 2025-08-20 | Zest Anchors, LLC | LOCATOR® Angled Abutment | |
| K251471 | 2025-08-20 | Implant Protesis Dental 2004, S.L. | IPD Dental Implant Abutments | |
| K251220 | 2025-07-28 | Infinitum Eta, Ltd. | NUVENTUS NV.C Prosthetic Components | |
| K241183 | 2025-07-28 | Seum Medi Co., Ltd. | ISO Abutment | |
| K250967 | 2025-06-26 | Open Implants, LLC | Sherlock | |
| K243009 | 2025-06-24 | Imagine Milling Technologies, LLC | MIST IC | FDA |
| K242978 | 2025-06-16 | Geomedi Co,., Ltd. | Geo Abutment | |
| K243530 | 2025-05-30 | Talladium España, SL | Dynamic TiBase | |
| K250614 | 2025-05-27 | Jjgc Indústria E Comércia DE Materiais | Neodent Implant System - Custom Abutments | |
| K250639 | 2025-05-22 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K243824 | 2025-05-08 | Preat Corporation | Preat Abutments | FDA |
| K243521 | 2025-05-01 | BioHorizons Implant Systems, Inc. | Conical Ti Base abutments | |
| K250295 | 2025-04-30 | Dentsply Sirona | Dentsply Sirona Titanium Bases system | |
| K242542 | 2025-04-22 | Medentika GmbH | Medentika CAD/CAM Abutments | |
| K250081 | 2025-04-11 | Dentsply Sirona | Atlantis® Abutments in Titanium | |
| K232383 | 2025-03-04 | Euroteknika | iPhysio® System | |
| K243278 | 2025-02-21 | Institut Straumann AG | Custom Abutments | |
| K243478 | 2025-02-19 | Institut Straumann AG | Straumann InLab Validated Workflow | |
| K243212 | 2025-02-14 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K242064 | 2025-01-17 | Smart Denture Conversions, LLC | Omni-Directional Multi-unit Abutment System (Trade N | FDA |
| K243272 | 2025-01-14 | Zest Anchors, LLC | LOCATOR Angled Abutment | |
| K242030 | 2025-01-13 | Megagen Implant Co., Ltd. | MegaGen Dental Implant Abutment | |
| K241003 | 2025-01-08 | Hiossen, Inc. | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment | |
| K240346 | 2025-01-03 | Nobel Biocare AB | NobelProcera Zirconia Implant Bridge | |
| K242819 | 2024-12-19 | Implant Protesis Dental 2004, S.L. | IPD Dental Implant Abutments | |
| K241616 | 2024-12-17 | Allonus Tech Co., Ltd. | ALLONUS Tech Prosthetics | |
| K242025 | 2024-12-10 | Elos Medtech Pinol A/S | Elos Accurate® Hybrid Base | |
| K242703 | 2024-12-05 | Ossvis Co., Ltd. | LW Pre-milled Abutment | |
| K242686 | 2024-12-04 | Jjgc Indústria E Comércia DE Materiais | Neodent Implant System | |
| K242245 | 2024-11-25 | Arum Dentistry Co., Ltd. | Customized Abutment | |
| K241575 | 2024-11-11 | Straumann USA, LLC | Straumann® Anatomic Healing Abutments XC (AHA) | |
| K242340 | 2024-11-05 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K241170 | 2024-10-21 | Talladium España, SL | Dynamic TiBase; TRI Screws | |
| K240725 | 2024-10-18 | Eclectic Co., Ltd. | PreXolid CAD/CAM abutments | FDA |
| K241485 | 2024-10-09 | Truabutment, Inc. | TruAbutment DS; TruBase | FDA |
| K234142 | 2024-09-18 | Megagen Implant Co., Ltd. | TiGEN Abutment, PMMA Abutment and Scan Healing Abutm | |
| K241722 | 2024-09-13 | Elos Medtech Pinol A/S | Elos Accurate® Hybrid Base; Elos Accurate® Customiz | |
| K240982 | 2024-08-26 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K231932 | 2024-08-20 | Techwin Co., Ltd. | TDS (TECHWIN DENTAL SYSTEM) | |
| K240531 | 2024-07-30 | BioHorizons Implant Systems, Inc. | SmartShape Healing Abutment; Wide Custom Milled Ti | FDA |
| K241063 | 2024-07-25 | Dentis Co., Ltd. | s-Clean ScanHealing Abutment | FDA |
| K241032 | 2024-07-15 | Biomet 3i, LLC | BellaTek Bars | |
| K240240 | 2024-07-12 | Prismatik Dentalcraft, Inc. | Inclusive® Titanium Abutments compatible with: Keyst | |
| K240570 | 2024-06-07 | Implant Protesis Dental 2004, S.L. | IPD Dental Implant Abutments | |
| K240603 | 2024-06-05 | Arum Dentistry Co., Ltd. | Ti-Base & Master Fix | |
| K233587 | 2024-06-03 | Zest Anchors, LLC | LOCATOR Angled Abutment (Various) | |
| K233389 | 2024-05-29 | Hiossen, Inc. | EK Digital Abutments | |
| K233285 | 2024-05-24 | Kuraray Noritake Dental, Inc. | KATANA Zirconia ONE For IMPLANT | |
| K231940 | 2024-05-15 | Prismatik Dentalcraft, Inc. | BruxZir® NOW SRC | |
| K234112 | 2024-05-09 | Arum Dentistry Co., Ltd. | Customized Abutment | |
| K234018 | 2024-05-07 | Dentsply Sirona | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D A | |
| K233857 | 2024-05-02 | JJGC Indústria e Comércio de Materiais | Neodent Implant System Custom Abutments | |
| K232528 | 2024-04-30 | Neobiotech Co., Ltd. | Protective Cap | |
| K240208 | 2024-04-24 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K223113 | 2024-04-15 | Medentika GmbH | Medentika Abutment System, Medentika CAD/CAM Abutmen | |
| K231132 | 2024-03-26 | J & P Dental Technologies | J & P Click Attachments | |
| K233167 | 2024-03-25 | Ossvis Co., Ltd. | LW Implant System Abutment | |
| K233083 | 2024-03-09 | Implant Solutions Pty Ltd (Aka Osteon | Osteon Precision Milled Suprastructure | |
| K231210 | 2024-03-05 | Modern Dental Laboratory (Dg) Co., Ltd | DGA Abutment | |
| K231915 | 2024-03-01 | Zfx GmbH - A Company of Zimvie | Zfx Abutments | |
| K231753 | 2024-02-21 | Oneday Biotech Co., Ltd. | Oneday Implant Abutment | |
| K233194 | 2024-02-20 | Osstem Implant Co., Ltd. | TS Abutment System | |
| K233208 | 2024-01-24 | Nobel Biocare AB | NobelProcera Titanium ASC Abutment, Omnigrip Clinica | |
| K233450 | 2024-01-22 | Megagen Implant Co., Ltd. | MegaGen Dental Implant Abutment - Scan Healing Abutm | |
| K232170 | 2024-01-12 | Izenimplant Co., Ltd. | Ti Link Abutment | |
| K233316 | 2024-01-05 | Terrats Medical SL | DESS Dental Smart Solutions | |
| K231072 | 2024-01-04 | Anthogyr | Anthogyr FlexiBase® titanium bases for Axiom® BL | |
| K231307 | 2023-12-21 | Elos Medtech Pinol A/S | Elos Accurate Customized Abutment | |
| K231411 | 2023-12-20 | Cowellmedi Co., Ltd. | INNO SLA Submerged Hybrid Ti-Base System | |
| K232560 | 2023-12-19 | Arum Dentistry Co., Ltd. | Angled Abutment | |
| K231803 | 2023-12-13 | JJGC Indústria e Comércio de Materiais | Neodent Implant System - Zirconia Implant System | |
| K232750 | 2023-12-08 | B.T.I. Biotechnology Institute, Sl. | BTI Interna Prosthetic Components | |
| K232220 | 2023-12-05 | Osstem Implant Co., Ltd. | SS Abutment System | |
| K232546 | 2023-11-21 | Cowellmedi Co., Ltd. | Meta G UCLA Abutment | |
| K231559 | 2023-11-17 | Talladium España, SL | Multi-Unit DAS System | |
| K231097 | 2023-11-14 | Prismatik Dentalcraft, Inc. | Inclusive® Titanium Abutments compatible with: Neoss | |
| K231874 | 2023-10-30 | Truabutment, Inc. | AOT & T-L Abutment | |
| K232271 | 2023-10-26 | Simda Co., Ltd. | SIMDA abutment | |
| K232151 | 2023-10-17 | Talladium España, SL | Dynamic TiBase | |
| K231413 | 2023-10-10 | Implant Protesis Dental 2004, S.L. | IPD Dental Implant Abutments | |
| K221972 | 2023-10-02 | Warantec Co., Ltd. | Warantec Custom Abutment | |
| K223496 | 2023-09-26 | Prismatik Dentalcraft, Inc. | Inclusive® Titanium Abutments compatible with: Strau | |
| K231235 | 2023-09-15 | Ossvis Co., Ltd. | LW UCLA Abutment | |
| K231827 | 2023-09-15 | B.T.I. Biotechnology Institute, Sl. | BTI Dental Implant System UnicCa® Aesthetic Post A |
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。