Product code DZEClass 2
Implant, Endosseous, Root-Form 510(k) Clearances
Product code DZE is the FDA classification for Implant, Endosseous, Root-Form, a Class 2 device regulated under 21 CFR 872.3640, reviewed by the FDA Dental panel. FDA has cleared 1,543 510(k) submissions under this product code.
Every device cleared under product code DZE shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.
- Cleared devices
- 1,543
- Device class
- Class 2
- Regulation
- 872.3640
- Latest clearance
- 2026-05-12
Cleared devices under product code DZE
Showing the 50 most recent of 1,543 cleared devices. Clearances from 2024-10-31 to 2026-05-12.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | 2026-05-12 |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | 2026-03-23 |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026-03-16 |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026-03-10 |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026-03-04 |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026-02-18 |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026-01-08 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 |
| K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | 2025-11-07 |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025-10-30 |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | 2025-10-10 |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-09-26 |
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | 2025-09-25 |
| K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | 2025-08-25 |
| 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 |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-08-18 |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-08-13 |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | 2025-08-12 |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2025-07-24 |
| K251280 | DESS® Dental Implants | Terrats Medical SL | 2025-07-23 |
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-07-23 |
| K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025-07-09 |
| K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | 2025-07-03 |
| K251660 | T3 Pro Implants ZimVie Packaging System | Biomet 3i, LLC | 2025-06-27 |
| K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | 2025-06-18 |
| K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | 2025-06-06 |
| K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | 2025-05-14 |
| K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025-05-08 |
| K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. | 2025-04-21 |
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025-02-24 |
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. | 2025-02-11 |
| K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. | 2025-01-29 |
| K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | 2025-01-08 |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-01-06 |
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | 2024-12-27 |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024-12-27 |
| K240435 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | 2024-12-20 |
| K243094 | Quickdent Dental Implant System | Quickdent Devices Private , Ltd. | 2024-12-19 |
| K243066 | Dental Implants and Abutments | Ditron Dental, Ltd. | 2024-12-16 |
| K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | 2024-12-10 |
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2024-11-25 |
| K233081 | NUVENTUS NV.C Dental Implant System | Infinitum Eta, Ltd. | 2024-11-15 |
| K242379 | LL Implant System | Ossvis Co., Ltd. | 2024-11-07 |
| K242261 | Accelx Implant System | Biotech Dental, LLC | 2024-11-06 |
| K240383 | Highness Implant System | Highness Co., Ltd. | 2024-10-31 |
Filing a 510(k) for a Implant, Endosseous, Root-Form of this type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.