DZE
- 产品代码
- DZE
- 器械名称
- Implant, Endosseous, Root-Form
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 872.3640
- 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)
- 1548 件
该代码近三年的 510(k)(100 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260463 | 2026-08-19 | Zeros Co., Ltd. | ZEROS Dental Implant System | |
| K251188 | 2026-06-25 | Uniqa Dental, Ltd. | UNIQA® Dental Implants System | |
| K251232 | 2026-06-18 | Megagen Implant Co., Ltd. | MegaGen Zygoma Dental Implant System | |
| K250806 | 2026-06-18 | A.B. Dental Devices , Ltd. | Dental Implant System | — |
| K260006 | 2026-06-17 | Inosys, Inc. | INOSS System | |
| K252731 | 2026-05-12 | Promimic AB | Promimic ZrP Surface Dental Implant; Promimic ZrP + | FDA |
| K252031 | 2026-03-23 | Adin Dental Implant Systems , Ltd. | Adin Long Dental Implant System | |
| K253334 | 2026-03-16 | Izenimplant Co., Ltd. | ZENEX Implant System_Short (R-System) | |
| K252168 | 2026-03-10 | Institut Straumann AG | Straumann® BLC Implants - Indication Widening | |
| K253493 | 2026-03-04 | Dentis Co., Ltd. | Dentis SQ-SL AXEL Fixture | |
| K252197 | 2026-02-18 | Nobel Biocare AB | Nobel Biocare S Series Implants | |
| K252286 | 2026-02-02 | Chengdu Besmile Medical Technology Co. | BIORES Dental Implant System | |
| K252585 | 2026-01-08 | Izenimplant Co., Ltd. | ZENEX Implant System_R-System | |
| K252145 | 2025-12-23 | Paragon Implant Mfg., LLC | GEN5 and GEN5+ 3.3mmD Dental Implants | |
| K250476 | 2025-12-23 | Paragon Implant Mfg., LLC | NizPlant Dental Implant System | |
| K251605 | 2025-12-22 | DIMPLO, Ltd. | DIMPLO Implant System | |
| K252090 | 2025-12-12 | JJGC Indústria e Comércio de Materiais | Pterygoid Indication for GM Helix Implants | |
| K251129 | 2025-11-07 | S.I.N. Implant System Ltda | S.I.N. Tapered Pro Conical Zygoma Implant System | |
| K251938 | 2025-10-30 | Paragon Implant Mfg., LLC | GEN5 and GEN5+ Dental Implant System | |
| K243078 | 2025-10-10 | Osseofuse International, Inc. | HexaPLUS S OneDrill Implant System | |
| K243983 | 2025-09-29 | Paltop Advanced Dental Solutions, Ltd. | Paltop Dental Implant System | |
| K251262 | 2025-09-26 | S.I.N. Implant System Ltda | S.I.N. Dental Implant System | |
| K251148 | 2025-09-25 | Jdentalcare Srl | JDEvolution Plus L and JDEvolution Plus LE | |
| K243834 | 2025-08-25 | Nobel Biocare AB | NobelZygoma TiUltra Implant system | |
| K251647 | 2025-08-21 | Dentsply Sirona, Inc. | MIS C1 Implant System, MIS Seven Implant System, MIS | |
| K250271 | 2025-08-18 | JJGC Indústria e Comércio de Materiais | Neodent Implant System - Zirconia Implant System | |
| K251046 | 2025-08-13 | S.I.N. Implant System Ltda | S.I.N. Dental Implant System | |
| K250294 | 2025-08-12 | Institut Straumann AG | Straumann® RidgeFit Implants | |
| K251297 | 2025-07-24 | Dentsply Sirona, Inc. | MIS LYNX Conical Connection Implant System | |
| K250280 | 2025-07-23 | Arum Dentistry Co., Ltd. | SD TL Implant System | |
| K251280 | 2025-07-23 | Terrats Medical SL | DESS® Dental Implants | |
| K243731 | 2025-07-09 | P&A USA | HEXIM Implant; Samwon General Abutments | |
| K243255 | 2025-07-03 | Truabutment, Inc. | URIS Long Implant & Abutments | |
| K251660 | 2025-06-27 | Biomet 3i, LLC | T3 Pro Implants ZimVie Packaging System | |
| K250872 | 2025-06-18 | Bioline Dental Implant Systems, Ltd. | Bioline Dental Implant System | |
| K243002 | 2025-06-06 | MBA Biotech Co., Ltd. | MBA Biotech Implant System | |
| K242072 | 2025-05-14 | Ceraroot SL | CeraRoot TL Implant System (TL) | |
| K233271 | 2025-05-08 | Synoross Dba Osseone | OsseOne Dental Implant System | FDA |
| K250176 | 2025-04-21 | D.A.N.D. Metal Industries North, Ltd. | DAND Dental Implant System | |
| K241703 | 2025-02-24 | Arum Dentistry Co., Ltd. | SD Implant System | FDA |
| K241462 | 2025-02-11 | Noris Medical , Ltd. | LONGY Implant and LONGY-N Implant | |
| K242217 | 2025-01-29 | Surcam Medical Devices and Development | Surcam Dental Implant System | |
| K242661 | 2025-01-08 | Tri Dental Implants Int. AG | TRI-matrix® X-Force Implants | |
| K242753 | 2025-01-06 | Arum Dentistry Co., Ltd. | SD TL Implant System | |
| K241127 | 2024-12-27 | Cowellmedi Co., Ltd. | INNO SLA Mini Plus® Implant System | |
| K241972 | 2024-12-27 | Megagen Implant Co., Ltd. | BLUEDIAMOND IMPLANT | |
| K240435 | 2024-12-20 | Alpha Dent Implants GmbH | Alpha Dent Implants Dental Implants System | |
| K243094 | 2024-12-19 | Quickdent Devices Private , Ltd. | Quickdent Dental Implant System | |
| K243066 | 2024-12-16 | Ditron Dental, Ltd. | Dental Implants and Abutments | |
| K241391 | 2024-12-10 | Institut Straumann AG | Straumann® PURE Ceramic Implants | |
| K241692 | 2024-11-25 | Dentsply Sirona, Inc. | MIS LYNX Conical Connection Implant System | |
| K233081 | 2024-11-15 | Infinitum Eta, Ltd. | NUVENTUS NV.C Dental Implant System | |
| K242379 | 2024-11-07 | Ossvis Co., Ltd. | LL Implant System | |
| K242261 | 2024-11-06 | Biotech Dental, LLC | Accelx Implant System | |
| K240383 | 2024-10-31 | Highness Co., Ltd. | Highness Implant System | |
| K240560 | 2024-10-30 | Izenimplant Co., Ltd. | ZENEX Implant System_Long | FDA |
| K241753 | 2024-10-23 | Biomet 3i, LLC | Immediate Molar Implants | |
| K240143 | 2024-10-11 | Jdentalcare Srl | JDZygoma dental implants | |
| K240262 | 2024-10-10 | B.T.I. Biotechnology Institute, Sl. | BTI Interna 3.0 Dental Implant System UnicCa® | |
| K240977 | 2024-09-13 | Denq | DenQ Sub SLA Implant System | |
| K240232 | 2024-09-13 | Hiossen, Inc. | EK D3.3 and Ultra Wide Implants | FDA |
| K240803 | 2024-09-12 | Surgikor, LLC | Surgikor Fixation One, Abutment Blanks and Abutments | |
| K231566 | 2024-09-05 | Medentis Medical GmbH | ICX-Implant System | |
| K231100 | 2024-08-23 | Proimtech Saglik Urunleri Anonim Sirke | Proimtech Dental Body Implant, Proimtech Abutment, P | |
| K233896 | 2024-08-16 | Jdentalcare Srl | JDentalCare Dental Implant System: JDEvolution; JDEv | FDA |
| K240837 | 2024-08-15 | Rdj Tov Implant, Ltd. | TOV Dental Implant System | |
| K233808 | 2024-07-31 | Ossvis Co., Ltd. | LW Narrow Implant System | FDA |
| K240609 | 2024-07-17 | S.I.N. - Sistema DE Implante Nacional | S.I.N. Dental Implant System | |
| K240966 | 2024-07-09 | Keystone Dental, Inc. | Prima Plus Conical Implant System | |
| K240202 | 2024-06-06 | Noris Medical , Ltd. | Conical Platform Dental Implants System | |
| K240187 | 2024-06-05 | BioHorizons Implant Systems, Inc. | Tapered Pro Conical Implant System | FDA |
| K232821 | 2024-05-31 | S.I.N. - Sistema DE Implante Nacional | S.I.N. Dental Implant System | |
| K231426 | 2024-05-24 | Hoowon Edi Co., Ltd. | 8plant Implant System | |
| K232740 | 2024-05-22 | Paltop Advanced Dental Solutions, Ltd. | Paltop Short Implants | |
| K240511 | 2024-05-20 | Dentis Co., Ltd. | Dentis s-Clean SQ-SL Fixture | |
| K233137 | 2024-05-16 | Mozograu S.A. | Ticare Dental Implant Systems | |
| K233231 | 2024-04-30 | Ditron Dental, Ltd. | Dental Implants and Abutments | |
| K240091 | 2024-04-26 | Arum Dentistry Co., Ltd. | NB Mini Implant System | |
| K221847 | 2024-04-11 | Newton Implant Systems, Inc. | Ni2 Implant System | |
| K232726 | 2024-04-01 | Southern Implants (Pty), Ltd. | External Hex Implant System | |
| K232049 | 2024-03-28 | Neobiotech Co., Ltd. | IS-III active Short Implant | |
| K232268 | 2024-03-25 | Zeros Co., Ltd. | STERI-OSS Implant System | |
| K234049 | 2024-03-20 | Institut Straumann AG | Straumann® BLC and TLC Implants - Line extension | |
| K221866 | 2024-01-18 | Newton Implant Systems, Inc. | S-Plant Dental Implant System | |
| K223714 | 2023-12-29 | Adin Dental Implant Systems , Ltd. | UniFit Dental Implant System | |
| K230438 | 2023-12-29 | Truabutment, Inc. | URIS Smart Path Implant System & Prosthetic | |
| K233163 | 2023-12-19 | Izenimplant Co., Ltd. | ZENEX Implant System_Short | |
| K231429 | 2023-12-18 | Idis Co., Ltd. | S-Plant Dental Implant System | |
| K231967 | 2023-12-07 | Megagen Implant Co., Ltd. | ARi ExCon Implant System | |
| K231127 | 2023-12-07 | S.I.N. - Sistema DE Implante Nacional | S.I.N. Dental Implant System | |
| K232418 | 2023-12-01 | Southern Implants (Pty), Ltd. | Single Platform SP1 Implant System | |
| K232099 | 2023-10-31 | JJGC Indústria e Comércio de Materiais | Neodent Implant System - GM Zygomatic Implant System | |
| K221315 | 2023-10-25 | Unidental Co., Ltd. | UNIdental Symphony Implant System | |
| K231395 | 2023-10-18 | Cowellmedi Co., Ltd. | INNO SLA Submerged Narrow Implant System | |
| K230104 | 2023-10-16 | Anthogyr | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit | |
| K223697 | 2023-10-13 | BioHorizons Implant Systems, Inc. | MRI compatibility for existing BioHorizons dental im | — |
| K230618 | 2023-10-11 | Megagen Implant Co., Ltd. | MegaGen Dental Implant Systems Portfolio - MR Condit | — |
| K230242 | 2023-10-05 | OsteoCentric Technologies | OsteoCentric Dental Implant System | FDA |
| K222778 | 2023-09-23 | Osstem Implant Co., Ltd. | Osstem Implant System | FDA |
| K230108 | 2023-09-14 | Institut Straumann AG | Straumann® BLC and TLC Implants |
FDA 官方分类页: DZE
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。