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
Feb 14, 2008
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
Ace Surgical Supply Co., Inc.
Dental
34d
Cleared
Feb 08, 2008
BIOHORIZONS INTERNAL IMPLANT SYSTEM
BioHorizons Implant Systems, Inc.
Dental
80d
Cleared
Feb 06, 2008
ATLAS IMPLANT SYSTEM
Cowellmedi Co., Ltd.
Dental
288d
Cleared
Feb 04, 2008
MS SYSTEM (DENTURE)
Osstem Implant Co., Ltd.
Dental
108d
Cleared
Jan 31, 2008
NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
Biomet 3i, Inc.
Dental
161d
Cleared
Jan 24, 2008
IMPLASA-HOECHST GMBH IMPLANTS
Implasa-Hoechst GmbH
Dental
266d
Cleared
Jan 14, 2008
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM
Odontit S.A.
Dental
94d
Cleared
Jan 11, 2008
NOBELREPLACE HEXAGONAL IMPLANT
Nobel Biocare USA, LLC
Dental
65d
Cleared
Jan 10, 2008
MS SYSTEM (PROVISIONAL)
Osstem Implant Co., Ltd.
Dental
93d
Cleared
Dec 28, 2007
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
Nobel Biocare AB
Dental
275d
Cleared
Dec 20, 2007
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
Nobel Biocare AB
Dental
58d
Cleared
Dec 13, 2007
SCREWPLUS DENTAL IMPLANTS (HA)
Implant Direct, LLC
Dental
45d
Cleared
Dec 12, 2007
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
Imtec Corp.
Dental
82d
Cleared
Dec 10, 2007
LEGACY DENTAL IMPLANTS
Implant Direct, LLC
Dental
45d
Cleared
Dec 06, 2007
SPI SYSTEM DENTAL IMPLANTS
Thommen Medical AG
Dental
78d
Cleared
Nov 28, 2007
IMPLUS IMPLANT SYSTEM
Leader Italia S.R.L.
Dental
426d
Cleared
Nov 16, 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
Southern Implants, Inc.
Dental
204d
Cleared
Nov 15, 2007
SPI CONTACT PLATFORM O 4.0 MM
Thommen Medical AG
Dental
30d
Cleared
Nov 09, 2007
T.B.R. ZIRCONNECT
Sudimplant SA
Dental
220d
Cleared
Nov 08, 2007
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
Dio Department Dsi, Inc.
Dental
253d
Cleared
Nov 06, 2007
GS FIXTURE SYSTEM
Osstem Implant Co., Ltd.
Dental
26d
Cleared
Oct 29, 2007
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX
Z-Systems AG
Dental
425d
Cleared
Oct 23, 2007
OLYMPUS DENTAL IMPLANT SYSTEM
Keystone Dental, Inc.
Dental
190d
Cleared
Oct 23, 2007
RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
Lifecore Biomedical, Inc.
Dental
25d