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 22, 2007
NANOTITE DENTAL IMPLANTS
Implant Innovations, Inc.
Dental
185d
Cleared
Feb 16, 2007
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16
Zimmer Dental, Inc.
Dental
86d
Cleared
Jan 10, 2007
SPI ELEMENT PLATFORM O 4.0 MM
Thommen Medical AG
Dental
7d
Cleared
Jan 05, 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
Nobel Biocare AB
Dental
22d
Cleared
Dec 19, 2006
NOBELPERFECT CONICAL CONNECTION
Nobel Biocare AB
Dental
82d
Cleared
Dec 08, 2006
MINISCREWS ANCHORING SYSTEM, M.A.S.
Micerium S.P.A.
Dental
116d
Cleared
Dec 06, 2006
NOBELREPLACE TAPERED CONICAL CONNECTION
Nobel Biocare USA, LLC
Dental
97d
Cleared
Nov 21, 2006
THE 5.0 X 6.0MM DENTAL IMPLANT
Bicon, Inc.
Dental
125d
Cleared
Nov 02, 2006
US SYSTEM
Osstem Implant Co., Ltd.
Dental
107d
Cleared
Nov 01, 2006
SS SYSTEM
Osstem Implant Co., Ltd.
Dental
105d
Cleared
Oct 20, 2006
P.0004 IMPLANTS
Institut Straumann AG
Dental
86d
Cleared
Oct 20, 2006
SUPER ORTHODONTIC SCREW
Osstem Implant Co., Ltd.
Dental
84d
Cleared
Sep 29, 2006
SPECTRA SYSTEM
Implant Direct, LLC
Dental
141d
Cleared
Sep 08, 2006
MODIFICATION TO: ORLUS MINI SCREW
Ortholution Co., Ltd.
Dental
322d
Cleared
Sep 08, 2006
SCREW-VENT IMPLANT SYSTEM, SV
Zimmer Dental, Inc.
Dental
109d
Cleared
Sep 08, 2006
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
Zimmer Dental, Inc.
Dental
81d
Cleared
Sep 05, 2006
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
Zimmer Dental, Inc.
Dental
29d
Cleared
Sep 01, 2006
SM IMPLANT SYSTEMS
Dio Department Dsi, Inc.
Dental
67d
Cleared
Aug 24, 2006
STRAUMANN NARROW NECK IMPLANTS
Straumann USA
Dental
139d
Cleared
Aug 11, 2006
STRAUMANN DENTAL IMPLANTS
Institut Straumann AG
Dental
106d
Cleared
Aug 09, 2006
ENHANCE DENTAL IMPLANT SYSTEM
Coastal Biocare
Dental
89d
Cleared
Aug 08, 2006
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
Sic Invent AG
Dental
69d
Cleared
Jun 30, 2006
SFB & CFB IMPLANTS
Nobel Biocare AB
Dental
80d
Cleared
Jun 20, 2006
ENDOSSEOUS DENTAL IMPLANT
Northern Implants, LLC
Dental
54d