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
Jan 28, 2022
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
Institut Straumann AG
Dental
170d
Cleared
Jan 07, 2022
EK Implants and Abutments System
Hiossen, Inc.
Dental
417d
Cleared
Jan 07, 2022
CORE1 Implant System
Cybermed, Inc.
Dental
366d
Cleared
Jan 05, 2022
Jplant
Jj Medical Co., Ltd.
Dental
194d
Cleared
Dec 21, 2021
TRI-matrix Implant Line
Tri Dental Implants Int. AG
Dental
371d
Cleared
Dec 21, 2021
N1 TiUltra TCC Implant System
Nobel Biocare Services AG
Dental
251d
Cleared
Dec 14, 2021
DESS Dental Implants
Terrats Medical SL
Dental
124d
Cleared
Nov 30, 2021
Paltop Narrow Implant
Paltop Advanced Dental Solutions, Ltd.
Dental
315d
Cleared
Nov 01, 2021
Alpha Dent Implants Dental Implants System
Alpha Dent Implants GmbH
Dental
252d
Cleared
Oct 20, 2021
S.I.N. Dental Implant System
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental
121d
Cleared
Oct 15, 2021
Magicore System
Innobiosurg Co., Ltd.
Dental
66d
Cleared
Sep 30, 2021
Implanova
Dental Evolutions, Inc.
Dental
219d
Cleared
Sep 24, 2021
Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
Nobel Biocare AG
Dental
79d
Cleared
Sep 23, 2021
ABC Dental Implant System
Abracadabra Implants , Ltd.
Dental
422d
Cleared
Aug 28, 2021
AnyOne External Implant System
Megagen Implant Co., Ltd.
Dental
267d
Cleared
Aug 27, 2021
PrimeTaper EV Dental Implant
Dentsply Sirona, Inc.
Dental
179d
Cleared
Aug 13, 2021
Neodent Implant System - Zirconia Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
189d
Cleared
Jul 29, 2021
BTI Extra-Short Dental Implant System UnicCa
B.T.I. Biotechnology Institute, Sl.
Dental
308d
Cleared
Jul 08, 2021
Straumann RidgeFit Implants
Institut Straumann AG
Dental
90d
Cleared
Jul 06, 2021
NUVO CF Implant System
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental
238d
Cleared
Jun 23, 2021
S.I.N. Dental Implant System
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental
184d
Cleared
Jun 22, 2021
AnyOne Onestage Implant System
Megagen Implant Co., Ltd.
Dental
152d
Cleared
Jun 21, 2021
Straumann BLX Implant System
Institut Straumann AG
Dental
90d
Cleared
Jun 18, 2021
Kontact Dental Implant System
Biotech Dental, Sas
Dental
142d