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 1,547 510(k) submissions under this product code.
Devices under product code DZEshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.
- Cleared devices
- 1,547
- Device class
- Class 2
- Regulation
- 872.3640
- Latest clearance
Cleared devices under product code DZE
Showing the 50 most recent of 1,547 cleared devices. Clearances from 2024-11-25 to 2026-06-25.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | |
| K260006 | INOSS System | Inosys, Inc. | |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | |
| K252145 | GEN5™ and GEN5+™ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | |
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | |
| K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | |
| 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. | |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | |
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | |
| K251280 | DESS® Dental Implants | Terrats Medical SL | |
| K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | |
| K243255 | URIS Long Implant & Abutments | Truabutment, Inc. | |
| K251660 | T3 Pro Implants– ZimVie Packaging System | Biomet 3i, LLC | |
| K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | |
| K243002 | MBA Biotech Implant System | MBA Biotech Co., Ltd. | |
| K242072 | CeraRoot TL Implant System (TL) | Ceraroot SL | |
| K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | |
| K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. | |
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | |
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. | |
| K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. | |
| K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | |
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | |
| K240435 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | |
| K243094 | Quickdent Dental Implant System | Quickdent Devices Private , Ltd. | |
| K243066 | Dental Implants and Abutments | Ditron Dental, Ltd. | |
| K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | |
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. |
Filing a 510(k) for a Implant, Endosseous, Root-Form of this type?
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