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
Nov 16, 2022
OmniTaper EV Dental Implants, DS Implants abutments with EV connection
Dentsply Sirona
Dental
216d
Cleared
Nov 09, 2022
Zaga Zygomatic System
Southern Implants (Pty), Ltd.
Dental
83d
Cleared
Oct 27, 2022
S.I.N. Dental Implant System
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental
94d
Cleared
Oct 19, 2022
Proximerge 2 Dental Implant System
Quadric Biomed, LLC
Dental
531d
Cleared
Oct 13, 2022
IM/ST Fixture System
Guilin Fiteeth Medical Instrument Co., Ltd.
Dental
413d
Cleared
Sep 19, 2022
NB 1 SA Implant System
Arum Dentistry Co., Ltd.
Dental
63d
Cleared
Sep 14, 2022
TSX Implants
Biomet 3i, LLC
Dental
163d
Cleared
Sep 06, 2022
Neodent Implant System - GM Narrow Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
218d
Cleared
Aug 10, 2022
BLT Dental Implant System
Bio Concept Co., Ltd.
Dental
376d
Cleared
Jul 21, 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa
B.T.I. Biotechnology Institute, Sl.
Dental
393d
Cleared
Jul 15, 2022
Tatum Surgical Dental Implant System
Suncoast Dental, Inc. Dba Tatum Surgical
Dental
247d
Cleared
Jul 15, 2022
Kontact Dental Implant System
Biotech Dental, Sas
Dental
206d
Cleared
Jul 13, 2022
SNUCONE Bone Level Implant System
Snucone Co., Ltd.
Dental
520d
Cleared
Jul 08, 2022
Adin Short Implants
Adin Dental Implants Systems , Ltd.
Dental
310d
Cleared
Jun 30, 2022
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
Blue Sky Bio, LLC
Dental
302d
Cleared
Jun 24, 2022
Noris Medical Dental Implants System - Cortical
Noris Medical , Ltd.
Dental
459d
Cleared
May 25, 2022
Paltop Conical Implant System
Paltop Advanced Dental Solutions, Ltd.
Dental
121d
Cleared
Apr 13, 2022
ZENEX Implant System
Izenimplant Co., Ltd.
Dental
366d
Cleared
Apr 06, 2022
NB 1 SA Implant System
Arum Dentistry Co., Ltd.
Dental
156d
Cleared
Apr 04, 2022
TRATE Dental Implant System
Trate AG
Dental
89d
Cleared
Mar 28, 2022
T3 Pro Implants
Biomet 3i, LLC
Dental
126d
Cleared
Mar 17, 2022
SICtapered & SICvantage tapered
Sic Invent AG
Dental
391d
Cleared
Mar 01, 2022
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Kj Meditech Co., Ltd.
Dental
586d
Cleared
Feb 23, 2022
SuperLine
Dentium Co., Ltd.
Dental
100d