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
Apr 28, 1995
DYNA IMPLANT DESIGN
Dyna Dental Engineering BV
Dental
798d
Cleared
Apr 26, 1995
KIS-II STR FIXTURES
Implant Center of the Palm Beaches
Dental
212d
Cleared
Apr 20, 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
Steri-Oss, Inc.
Dental
50d
Cleared
Apr 14, 1995
STERI-OSS SCALER FOR DENTAL IMPLANTS
Steri-Oss, Inc.
Dental
262d
Cleared
Apr 13, 1995
BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
Nobelpharma USA, Inc.
Dental
161d
Cleared
Mar 31, 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
Lifecore Biomedical, Inc.
Dental
21d
Cleared
Mar 29, 1995
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT
Steri-Oss, Inc.
Dental
215d
Cleared
Mar 24, 1995
ITI TRANSVERSAL SCREWING SYSTEM
The Straumann Co.
Dental
235d
Cleared
Mar 13, 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION
Implant Innovations International, Inc.
Dental
486d
Cleared
Mar 13, 1995
OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL
Opti-Max
Dental
157d
Cleared
Mar 08, 1995
BRANEMARK SYSTEM 3.3MM FIXTURE
Nobelpharma USA, Inc.
Dental
167d
Cleared
Mar 01, 1995
KIS-II IMPLANT FIXTURES
Implant Center of the Palm Beaches
Dental
198d
Cleared
Mar 01, 1995
KIS-II NON-ANGULATED ABUTMENTS
Implant Center of the Palm Beaches
Dental
197d
Cleared
Mar 01, 1995
IMPLANT BODY RETRIEVER/REMOVER
"O" Co., Inc.
Dental
76d
Cleared
Mar 01, 1995
IMPLANT BODY DEPTH GAUGE/TRYIN
"O" Co., Inc.
Dental
75d
Cleared
Feb 28, 1995
RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM
Lifecore Biomedical, Inc.
Dental
194d
Cleared
Feb 28, 1995
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
Nobelpharma USA, Inc.
Dental
144d
Cleared
Feb 27, 1995
BRANEMARK SYSTEM 17 ANGULATED ABUTMENT
Nobelpharma USA, Inc.
Dental
143d
Cleared
Feb 17, 1995
BRANEMARK SYSTEM SMILINE II
Nobelpharma USA, Inc.
Dental
133d
Cleared
Feb 16, 1995
PARRALLEL PIN
"O" Co., Inc.
Dental
134d
Cleared
Feb 16, 1995
ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT
"O" Co., Inc.
Dental
108d
Cleared
Feb 13, 1995
ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
Innova Corp.
Dental
784d
Cleared
Feb 02, 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)
Lifecore Biomedical, Inc.
Dental
171d
Cleared
Dec 05, 1994
KIS-II IMPLANT SYSTEM/DRILLS
Implant Center of the Palm Beaches
Dental
111d