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 Southern Implants (Pty), Ltd..
1543
Total
1543
Cleared
202d
Avg days
1976
Since
1543 devices
Cleared
Sep 25, 2020
Honorst Implant System
Medimecca Co., Ltd.
Dental
64d
Cleared
Sep 23, 2020
IBS Implant System
Innobiosurg Co., Ltd.
Dental
26d
Cleared
Sep 04, 2020
Neodent Implant System - GM Helix Implants 7.0
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
121d
Cleared
Sep 03, 2020
MIS Dental Implant System
Dentsply Sirona
Dental
230d
Cleared
Aug 27, 2020
Nucleoss T6 Dental Implant System
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST
Dental
392d
Cleared
Aug 27, 2020
Magicore System
Innobiosurg Co., Ltd.
Dental
42d
Cleared
Aug 20, 2020
Straumann TLX Implant System
Institut Straumann AG
Dental
167d
Cleared
Aug 18, 2020
Keystone Dental XL Dental Implant System
Keystone Dental, Inc.
Dental
90d
Cleared
Jul 31, 2020
I Do
I DO Biotech Co., Ltd.
Dental
343d
Cleared
Jun 26, 2020
JDentalCare Implant System JDIcon
Jdentalcare Srl
Dental
694d
Cleared
Jun 26, 2020
MSDI Dental Implants System
Medical Systems and Devices International , Ltd.
Dental
393d
Cleared
Jun 25, 2020
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants
Implant Direct Sybron Manufacturing, LLC
Dental
315d
Cleared
Jun 19, 2020
Fit & Brilliant Dental Implant System
F&B Technology Co., Ltd.
Dental
465d
Cleared
Jun 18, 2020
BV Dental Implant System
Bio Concept Co., Ltd.
Dental
301d
Cleared
Jun 18, 2020
NUVO IF Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
206d
Cleared
May 14, 2020
S.I.N. Dental Implant System
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental
189d
Cleared
May 07, 2020
ZAGA Zygomatic System
Southern Implants (Pty), Ltd.
Dental
226d
Cleared
Apr 28, 2020
Magicore II System
Innobiosurg Co., Ltd.
Dental
259d
Cleared
Apr 28, 2020
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
127d
Cleared
Apr 28, 2020
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
Novodent SA
Dental
27d
Cleared
Apr 13, 2020
s-Clean SQ-SL Implant System Mini
Dentis Co., Ltd.
Dental
88d
Cleared
Apr 03, 2020
Faico Dental Implant System
Faico Medical, LLC
Dental
249d
Cleared
Apr 01, 2020
DSI Dental Implant System
Dsi Dental Solutions, Ltd.
Dental
68d
Cleared
Feb 27, 2020
ST Internal Implant System
T-Plus Implant Tech. Co., Ltd.
Dental
324d