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
Mar 30, 2018
UF(II) Implant System
Dio Corporation
Dental
394d
Cleared
Feb 27, 2018
Zygomatic Implant System
Southern Implants (Pty), Ltd.
Dental
126d
Cleared
Feb 10, 2018
TAV Medical Dental Implants System
Tav Medical , Ltd.
Dental
389d
Cleared
Feb 09, 2018
BR Type Implant System
Biotem Co., Ltd.
Dental
291d
Cleared
Jan 31, 2018
AR_N Type Implant System
Biotem Co., Ltd.
Dental
274d
Cleared
Jan 31, 2018
SPI Dental Implant System
Msi France
Dental
189d
Cleared
Jan 19, 2018
Straumann Dental Implant System
Straumann USA, LLC
Dental
218d
Cleared
Oct 20, 2017
TREFOIL System
Nobel Biocare AB
Dental
78d
Cleared
May 11, 2017
TREFOIL System
Nobel Biocare AB
Dental
114d
Cleared
Mar 14, 2017
NobelZygoma 0°
Nobel Biocare AB
Dental
278d
Cleared
Mar 04, 1997
DENTSPLY PRECISION TORQUE SYSTEM
Dentsply Intl.
Dental
146d
Cleared
Sep 29, 1994
LORENZ SURGICAL THREADED DENTAL IMPLANT
Biomet, Inc.
Dental
178d
Cleared
Sep 29, 1994
LORENZ SURGICAL CYLINDER DENTAL IMPLANT
Biomet, Inc.
Dental
178d
Cleared
Sep 29, 1994
LORENZ SURGICAL FINNED DENTAL IMPLANT
Biomet, Inc.
Dental
178d
Cleared
Jun 04, 1987
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
Depuy, Inc.
Dental
69d