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
Jun 17, 2021
MIS Lance+ Conical Connection Dental Implant System
Dentsply Sirona
Dental
84d
Cleared
Jun 04, 2021
Dentis s-Clean s-Line Mini
Dentis Co., Ltd.
Dental
143d
Cleared
May 26, 2021
Implacil Implant System
Implacil DE Bortoli Material Odontologico Ltda
Dental
243d
Cleared
May 14, 2021
BoneTrust Mini Implant System
Medical Instinct Deutschland GmbH
Dental
435d
Cleared
Apr 22, 2021
IDCAM Dental Implants
Implants Diffusion International
Dental
437d
Cleared
Apr 19, 2021
Dentis s-Clean s-Line
Dentis Co., Ltd.
Dental
90d
Cleared
Apr 15, 2021
Locator Overdenture Implant System
Ivory Super Holdco Inc. / Zest Anchors, LLC
Dental
118d
Cleared
Mar 18, 2021
s-Clean SQ-SL Implant System Mini
Dentis Co., Ltd.
Dental
178d
Cleared
Mar 15, 2021
Neodent Implant System-Easy Pack
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
118d
Cleared
Feb 17, 2021
s-Clean SQ-SL Implant System Regular
Dentis Co., Ltd.
Dental
29d
Cleared
Feb 11, 2021
DSP Implant System
D.S.P Industrial Eireli
Dental
504d
Cleared
Feb 08, 2021
Straumann 4 mm Short Implants
Straumann USA, LLC
Dental
131d
Cleared
Jan 22, 2021
Simply Iconic Implants
Implant Direct Sybron Manufacturing, LLC
Dental
226d
Cleared
Jan 13, 2021
BEGO Semados® RS/RSX Implant System
Bego Implant Systems GmbH & Co. KG
Dental
205d
Cleared
Dec 22, 2020
Neodent Implant System - Zirconia Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
201d
Cleared
Dec 01, 2020
Z5-TL
Z-Systems AG
Dental
161d
Cleared
Nov 17, 2020
S.I.N. Dental Implant System
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental
216d
Cleared
Nov 16, 2020
TiUltra Implants and Xeal Abutments
Nobel Biocare AB
Dental
90d
Cleared
Nov 10, 2020
JTK Dental Implant System
Jiangyin Jintech Biotech Co., Ltd.
Dental
739d
Cleared
Oct 20, 2020
MS Lide Implant Systems
Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.
Dental
868d
Cleared
Oct 16, 2020
MINICONE Implant
Medentika GmbH
Dental
193d
Cleared
Oct 14, 2020
Z5-BL
Z-Systems AG
Dental
239d
Cleared
Oct 07, 2020
URIS OMNI Narrow System & Prosthetic
Truabutment, Inc.
Dental
191d
Cleared
Sep 29, 2020
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
Altatec GmbH
Dental
298d