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
Apr 26, 2024
NB Mini Implant System
Arum Dentistry Co., Ltd.
Dental
105d
Cleared
Apr 11, 2024
Ni2 Implant System
Newton Implant Systems, Inc.
Dental
657d
Cleared
Apr 01, 2024
External Hex Implant System
Southern Implants (Pty), Ltd.
Dental
208d
Cleared
Mar 28, 2024
IS-III active Short Implant
Neobiotech Co., Ltd.
Dental
262d
Cleared
Mar 25, 2024
STERI-OSS Implant System
Zeros Co., Ltd.
Dental
238d
Cleared
Mar 20, 2024
Straumann® BLC and TLC Implants - Line extension
Institut Straumann AG
Dental
90d
Cleared
Jan 18, 2024
S-Plant Dental Implant System
Newton Implant Systems, Inc.
Dental
570d
Cleared
Dec 29, 2023
UniFit Dental Implant System
Adin Dental Implant Systems , Ltd.
Dental
382d
Cleared
Dec 29, 2023
URIS Smart Path Implant System & Prosthetic
Truabutment, Inc.
Dental
311d
Cleared
Dec 19, 2023
ZENEX Implant System_Short
Izenimplant Co., Ltd.
Dental
83d
Cleared
Dec 18, 2023
S-Plant Dental Implant System
Idis Co., Ltd.
Dental
215d
Cleared
Dec 07, 2023
S.I.N. Dental Implant System
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental
231d
Cleared
Dec 07, 2023
ARi ExCon Implant System
Megagen Implant Co., Ltd.
Dental
157d
Cleared
Dec 01, 2023
Single Platform SP1 Implant System
Southern Implants (Pty), Ltd.
Dental
112d
Cleared
Oct 31, 2023
Neodent Implant System - GM Zygomatic Implant System
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental
110d
Cleared
Oct 25, 2023
UNIdental Symphony Implant System
Unidental Co., Ltd.
Dental
537d
Cleared
Oct 18, 2023
INNO SLA Submerged Narrow Implant System
Cowellmedi Co., Ltd.
Dental
156d
Cleared
Oct 16, 2023
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
Anthogyr
Dental
276d
Cleared
Oct 13, 2023
MRI compatibility for existing BioHorizons dental implants and abutments
BioHorizons Implant Systems, Inc.
Dental
308d
Cleared
Oct 11, 2023
MegaGen Dental Implant Systems Portfolio - MR Conditional
Megagen Implant Co., Ltd.
Dental
219d
Cleared
Oct 05, 2023
OsteoCentric Dental Implant System
OsteoCentric Technologies
Dental
248d
Cleared
Sep 23, 2023
Osstem Implant System
Osstem Implant Co., Ltd.
Dental
374d
Cleared
Sep 14, 2023
Straumann® BLC and TLC Implants
Institut Straumann AG
Dental
244d
Cleared
Aug 23, 2023
Oneday Mini Implant System
Oneday Biotech Co., Ltd.
Dental
330d