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 Nobelpharma USA, Inc., Steri-Oss, Inc. and Implant Innovations, Inc..
1550
Total
1550
Cleared
203d
Avg days
1976
Since
1550 devices
Cleared
Dec 08, 2005
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Northern Implants, LLC
Dental
87d
Cleared
Dec 02, 2005
BIOHORIZONS SINGLE-STAGE IMPLANT
BioHorizons Implant Systems, Inc.
Dental
22d
Cleared
Oct 21, 2005
MODUS IMF SCREWS 2.0
Medartis, Inc.
Dental
84d
Cleared
Oct 14, 2005
MILO DENTAL IMPLANT SYSTEM
Intra-Lock International
Dental
179d
Cleared
Sep 23, 2005
SISTEMA DE IMPLANTE NACIONAL (S.I.N.)
Sin Sistema DE Implante Nacional Ltda
Dental
77d
Cleared
Sep 20, 2005
MAXIMUS 3.0 AND OS IMPLANTS
BioHorizons Implant Systems, Inc.
Dental
18d
Cleared
Sep 19, 2005
O.A.S.I. SYSTEM
Lancer Orthodontics, Inc.
Dental
98d
Cleared
Sep 15, 2005
3I OSSEOTITE DENTAL IMPLANTS
Implant Innovations, Inc.
Dental
104d
Cleared
Sep 09, 2005
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
Lifecore Biomedical, Inc.
Dental
84d
Cleared
Sep 02, 2005
INTERMEZZO IMPLANT SYSTEMS
Megagen Co., Ltd.
Dental
134d
Cleared
Sep 02, 2005
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
Blue Sky Bio, LLC
Dental
87d
Cleared
Sep 01, 2005
AVANA DENTAL IMPLANT SYSTEM
Osstem Co., Ltd.
Dental
79d
Cleared
Jul 28, 2005
ALLFIM IMPLANT SYSTEMS
Cowellmedi Co., Ltd.
Dental
119d
Cleared
Jun 21, 2005
SPI DENTAL IMPLANT
Thommen Medical AG
Dental
14d
Cleared
Jun 15, 2005
MEDICON IMF-ORION SCREWS
Medicon EG
Dental
111d
Cleared
Jun 08, 2005
NOBELSPEEDY IMPLANTS
Nobel Biocare AB
Dental
111d
Cleared
Jun 08, 2005
PREVAIL DENTAL IMPLANTS
Implant Innovations, Inc.
Dental
29d
Cleared
Jun 01, 2005
ORLUS MINI SCREW
Ortholution Co., Ltd.
Dental
89d
Cleared
May 19, 2005
TIUNITE IMPLANTS
Nobel Biocare AB
Dental
62d
Cleared
May 04, 2005
THE GUIDED SURGERY CONCEPT
Nobel Biocare AB
Dental
77d
Cleared
Apr 22, 2005
4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
Bicon, Inc.
Dental
36d
Cleared
Apr 19, 2005
GROOVY IMPLANTS
Nobel Biocare AB
Dental
75d
Cleared
Apr 15, 2005
PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS
Lifecore Biomedical, Inc.
Dental
46d
Cleared
Apr 13, 2005
SIC PRO
Sic Invent AG
Dental
384d