FDA Product Code DZE: Implant, Endosseous, Root-form
Root-form dental implants are the standard of care for replacing missing teeth. FDA product code DZE covers endosseous root-form implants — titanium or zirconia fixtures that are surgically placed into the jawbone to support prosthetic restorations.
These implants osseointegrate with the surrounding bone to provide a stable, long-term foundation for crowns, bridges, and full-arch rehabilitations. They are used by oral surgeons, periodontists, and implantologists.
DZE devices are Class II medical devices, regulated under 21 CFR 872.3640 and reviewed by the FDA Dental panel.
Leading manufacturers include Institut Straumann AG, Jjgc Industria E Comercio DE Materiais Dentarios S.A. and Megagen Implant Co., Ltd..
1543
Total
1543
Cleared
202d
Avg days
1976
Since
1543 devices
Cleared
Jul 23, 2025
SD TL Implant System
Arum Dentistry Co., Ltd.
Dental
173d
Cleared
Jul 23, 2025
DESS® Dental Implants
Terrats Medical SL
Dental
90d
Cleared
Jul 09, 2025
HEXIM Implant
P&A USA
Dental
217d
Cleared
Jul 03, 2025
URIS Long Implant & Abutments
Truabutment, Inc.
Dental
261d
Cleared
Jun 27, 2025
T3 Pro Implants– ZimVie Packaging System
Biomet 3i, LLC
Dental
28d
Cleared
Jun 18, 2025
Bioline Dental Implant System
Bioline Dental Implant Systems, Ltd.
Dental
86d
Cleared
Jun 06, 2025
MBA Biotech Implant System
MBA Biotech Co., Ltd.
Dental
253d
Cleared
May 14, 2025
CeraRoot TL Implant System (TL)
Ceraroot SL
Dental
302d
Cleared
May 08, 2025
OsseOne Dental Implant System
Synoross Dba Osseone
Dental
587d
Cleared
Apr 21, 2025
DAND Dental Implant System
D.A.N.D. Metal Industries North, Ltd.
Dental
89d
Cleared
Feb 24, 2025
SD Implant System
Arum Dentistry Co., Ltd.
Dental
256d
Cleared
Feb 11, 2025
LONGY Implant and LONGY-N Implant
Noris Medical , Ltd.
Dental
264d
Cleared
Jan 29, 2025
Surcam Dental Implant System
Surcam Medical Devices and Developments, Ltd.
Dental
184d
Cleared
Jan 08, 2025
TRI-matrix® X-Force Implants
Tri Dental Implants Int. AG
Dental
126d
Cleared
Jan 06, 2025
SD TL Implant System
Arum Dentistry Co., Ltd.
Dental
116d
Cleared
Dec 27, 2024
INNO SLA Mini Plus® Implant System
Cowellmedi Co., Ltd.
Dental
248d
Cleared
Dec 27, 2024
BLUEDIAMOND IMPLANT
Megagen Implant Co., Ltd.
Dental
175d
Cleared
Dec 20, 2024
Alpha Dent Implants Dental Implants System
Alpha Dent Implants GmbH
Dental
310d
Cleared
Dec 19, 2024
Quickdent Dental Implant System
Quickdent Devices Private , Ltd.
Dental
80d
Cleared
Dec 16, 2024
Dental Implants and Abutments
Ditron Dental, Ltd.
Dental
80d
Cleared
Dec 10, 2024
Straumann® PURE Ceramic Implants
Institut Straumann AG
Dental
209d
Cleared
Nov 25, 2024
MIS LYNX Conical Connection Implant System
Dentsply Sirona, Inc.
Dental
166d
Cleared
Nov 15, 2024
NUVENTUS NV.C™ Dental Implant System
Infinitum Eta, Ltd.
Dental
416d
Cleared
Nov 07, 2024
LL Implant System
Ossvis Co., Ltd.
Dental
87d