FDA Product Code
FDA Product Code DZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3640
510(k) Clearances — 1,549 records · page 1 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | 2026-09-17 | Abbreviated | PDF ↗ |
| K260463 | ZEROS Dental Implant System | Zeros Co., Ltd. | 2026-08-19 | Special | PDF ↗ |
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | 2026-06-25 | Traditional | PDF ↗ |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K260006 | INOSS System | Inosys, Inc. | 2026-06-17 | Traditional | PDF ↗ |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | 2026-05-12 | Traditional | PDF ↗ |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | 2026-03-23 | Traditional | PDF ↗ |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026-03-16 | Traditional | PDF ↗ |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026-03-10 | Traditional | PDF ↗ |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026-03-04 | Traditional | PDF ↗ |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026-02-18 | Traditional | PDF ↗ |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 | Abbreviated | PDF ↗ |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026-01-08 | Traditional | PDF ↗ |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 | Abbreviated | PDF ↗ |
| K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 | Traditional | PDF ↗ |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 | Traditional | PDF ↗ |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 | Traditional | PDF ↗ |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | 2025-11-07 | Traditional | PDF ↗ |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025-10-30 | Traditional | PDF ↗ |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | 2025-10-10 | Traditional | PDF ↗ |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 | Traditional | PDF ↗ |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-09-26 | Traditional | PDF ↗ |
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | 2025-09-25 | Traditional | PDF ↗ |
| K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | 2025-08-25 | Traditional | PDF ↗ |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | Dentsply Sirona, Inc. | 2025-08-21 | Traditional | PDF ↗ |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-08-18 | Traditional | PDF ↗ |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-08-13 | Traditional | PDF ↗ |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | 2025-08-12 | Traditional | PDF ↗ |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2025-07-24 | Traditional | PDF ↗ |
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-07-23 | Traditional | PDF ↗ |
| K251280 | DESS® Dental Implants | Terrats Medical SL | 2025-07-23 | Traditional | PDF ↗ |
| K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025-07-09 | Traditional | PDF ↗ |
| K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | 2025-07-03 | Traditional | PDF ↗ |
| K251660 | T3 Pro Implants ZimVie Packaging System | Biomet 3i, LLC | 2025-06-27 | Special | PDF ↗ |
| K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | 2025-06-18 | Traditional | PDF ↗ |
| K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | 2025-06-06 | Traditional | PDF ↗ |
| K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | 2025-05-14 | Traditional | PDF ↗ |
| K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025-05-08 | Traditional | PDF ↗ |
| K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. | 2025-04-21 | Traditional | PDF ↗ |
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025-02-24 | Traditional | PDF ↗ |
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. | 2025-02-11 | Traditional | PDF ↗ |
| K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. | 2025-01-29 | Traditional | PDF ↗ |
| K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | 2025-01-08 | Traditional | PDF ↗ |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-01-06 | Traditional | PDF ↗ |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024-12-27 | Traditional | PDF ↗ |
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | 2024-12-27 | Traditional | PDF ↗ |
| K240435 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | 2024-12-20 | Traditional | PDF ↗ |
| K243094 | Quickdent Dental Implant System | Quickdent Devices Private , Ltd. | 2024-12-19 | Traditional | PDF ↗ |
| K243066 | Dental Implants and Abutments | Ditron Dental, Ltd. | 2024-12-16 | Traditional | PDF ↗ |
| K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | 2024-12-10 | Traditional | PDF ↗ |
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2024-11-25 | Traditional | PDF ↗ |
| K233081 | NUVENTUS NV.C Dental Implant System | Infinitum Eta, Ltd. | 2024-11-15 | Traditional | PDF ↗ |
| K242379 | LL Implant System | Ossvis Co., Ltd. | 2024-11-07 | Traditional | PDF ↗ |
| K242261 | Accelx Implant System | Biotech Dental, LLC | 2024-11-06 | Traditional | PDF ↗ |
| K240383 | Highness Implant System | Highness Co., Ltd. | 2024-10-31 | Traditional | PDF ↗ |
| K240560 | ZENEX Implant System_Long | Izenimplant Co., Ltd. | 2024-10-30 | Traditional | PDF ↗ |
| K241753 | Immediate Molar Implants | Biomet 3i, LLC | 2024-10-23 | Traditional | PDF ↗ |
| K240143 | JDZygoma dental implants | Jdentalcare Srl | 2024-10-11 | Traditional | PDF ↗ |
| K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | B.T.I. Biotechnology Institute, Sl. | 2024-10-10 | Traditional | PDF ↗ |
| K240232 | EK D3.3 and Ultra Wide Implants | Hiossen, Inc. | 2024-09-13 | Traditional | PDF ↗ |
| K240977 | DenQ Sub SLA Implant System | Denq | 2024-09-13 | Traditional | PDF ↗ |
| K240803 | Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC | 2024-09-12 | Traditional | PDF ↗ |
| K231566 | ICX-Implant System | Medentis Medical GmbH | 2024-09-05 | Traditional | PDF ↗ |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw | Proimtech Saglik Urunleri Anonim Sirketi | 2024-08-23 | Traditional | PDF ↗ |
| K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | Jdentalcare Srl | 2024-08-16 | Traditional | PDF ↗ |
| K240837 | TOV Dental Implant System | Rdj Tov Implant, Ltd. | 2024-08-15 | Traditional | PDF ↗ |
| K233808 | LW Narrow Implant System | Ossvis Co., Ltd. | 2024-07-31 | Traditional | PDF ↗ |
| K240609 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-17 | Traditional | PDF ↗ |
| K240966 | Prima Plus Conical Implant System | Keystone Dental, Inc. | 2024-07-09 | Traditional | PDF ↗ |
| K240202 | Conical Platform Dental Implants System | Noris Medical , Ltd. | 2024-06-06 | Traditional | PDF ↗ |
| K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024-06-05 | Traditional | PDF ↗ |
| K232821 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-05-31 | Traditional | PDF ↗ |
| K231426 | 8plant Implant System | Hoowon Edi Co., Ltd. | 2024-05-24 | Traditional | PDF ↗ |
| K232740 | Paltop Short Implants | Paltop Advanced Dental Solutions, Ltd. | 2024-05-22 | Traditional | PDF ↗ |
| K240511 | Dentis s-Clean SQ-SL Fixture | Dentis Co., Ltd. | 2024-05-20 | Traditional | PDF ↗ |
| K233137 | Ticare Dental Implant Systems | Mozograu S.A. | 2024-05-16 | Abbreviated | PDF ↗ |
| K233231 | Dental Implants and Abutments | Ditron Dental, Ltd. | 2024-04-30 | Traditional | PDF ↗ |
| K240091 | NB Mini Implant System | Arum Dentistry Co., Ltd. | 2024-04-26 | Traditional | PDF ↗ |
| K221847 | Ni2 Implant System | Newton Implant Systems, Inc. | 2024-04-11 | Traditional | PDF ↗ |
| K232726 | External Hex Implant System | Southern Implants (Pty), Ltd. | 2024-04-01 | Traditional | PDF ↗ |
| K232049 | IS-III active Short Implant | Neobiotech Co., Ltd. | 2024-03-28 | Traditional | PDF ↗ |
| K232268 | STERI-OSS Implant System | Zeros Co., Ltd. | 2024-03-25 | Traditional | PDF ↗ |
| K234049 | Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG | 2024-03-20 | Traditional | PDF ↗ |
| K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024-01-18 | Traditional | PDF ↗ |
| K223714 | UniFit Dental Implant System | Adin Dental Implant Systems , Ltd. | 2023-12-29 | Traditional | PDF ↗ |
| K230438 | URIS Smart Path Implant System & Prosthetic | Truabutment, Inc. | 2023-12-29 | Traditional | PDF ↗ |
| K233163 | ZENEX Implant System_Short | Izenimplant Co., Ltd. | 2023-12-19 | Traditional | PDF ↗ |
| K231429 | S-Plant Dental Implant System | Idis Co., Ltd. | 2023-12-18 | Traditional | PDF ↗ |
| K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023-12-07 | Traditional | PDF ↗ |
| K231127 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2023-12-07 | Traditional | PDF ↗ |
| K232418 | Single Platform SP1 Implant System | Southern Implants (Pty), Ltd. | 2023-12-01 | Traditional | PDF ↗ |
| K232099 | Neodent Implant System - GM Zygomatic Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-10-31 | Traditional | PDF ↗ |
| K221315 | UNIdental Symphony Implant System | Unidental Co., Ltd. | 2023-10-25 | Traditional | PDF ↗ |
| K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023-10-18 | Traditional | PDF ↗ |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | Anthogyr | 2023-10-16 | Traditional | PDF ↗ |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | BioHorizons Implant Systems, Inc. | 2023-10-13 | Traditional | PDF ↗ |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. | 2023-10-11 | Traditional | PDF ↗ |
| K230242 | OsteoCentric Dental Implant System | OsteoCentric Technologies | 2023-10-05 | Traditional | PDF ↗ |
| K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023-09-23 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.