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 19, 1991
CORE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
Core-Vent Corp.
Dental
399d
Cleared
Feb 11, 1991
CASTABLE ABUTMENTS
Calcitek, Inc.
Dental
363d
Cleared
Feb 05, 1991
INTERPORE CYLINDRICAL HEX IMPLANT
Interpore Intl.
Dental
117d
Cleared
Jan 29, 1991
DEVICE PART NUMBER DPI-1106 IMPLANT
Minimatic Implant Technology
Dental
210d
Cleared
Jan 29, 1991
TITANIUM COC ABUTMENT HEADS FOR IMZ
Implant Support Systems, Inc.
Dental
111d
Cleared
Jan 15, 1991
THE O-RING SYSTEM - ORS
Attachments Intl., Inc.
Dental
372d
Cleared
Jan 14, 1991
BC 1220 ANALOG - IMPLANT BODY
Minimatic Implant Technology
Dental
90d
Cleared
Jan 04, 1991
HA-TI (HAND-TITANIUM SCREW) IMPLANT
Mathys Corp. of North America
Dental
249d
Cleared
Dec 27, 1990
CGA-112 COPING GOLD ALLOY
Minimatic Implant Technology
Dental
167d
Cleared
Dec 26, 1990
A-1101 CAST ABUTMENT
Minimatic Implant Technology
Dental
168d
Cleared
Dec 17, 1990
SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
Core-Vent Corp.
Dental
164d
Cleared
Nov 30, 1990
A-1107 ABUTMENT (FIXED)
Minimatic Implant Technology
Dental
142d
Cleared
Nov 26, 1990
A-1103 ABUTMENT (REMOVABLE)
Minimatic Implant Technology
Dental
138d
Cleared
Nov 20, 1990
DEVICE PART NUMBER: SVD-3S DRILL
Minimatic Implant Technology
Dental
138d
Cleared
Nov 20, 1990
TC-1111 TRANSFER PIN
Minimatic Implant Technology
Dental
132d
Cleared
Nov 20, 1990
ABO-1122 ANALOG BALL OVERDENTURE
Minimatic Implant Technology
Dental
109d
Cleared
Nov 20, 1990
SATC-1114, SHOULDER ABUTMENT TRANSFER COPING
Minimatic Implant Technology
Dental
50d
Cleared
Nov 13, 1990
DEVICE PART NUMBER SVD2, 3, 4 SPADE DRILL
Minimatic Implant Technology
Dental
133d
Cleared
Nov 13, 1990
DEVICE PART NUMBER: PD-12 PILOT DRILL
Minimatic Implant Technology
Dental
131d
Cleared
Nov 13, 1990
AA-1110 ANALOG ABUTMENT
Minimatic Implant Technology
Dental
125d
Cleared
Nov 13, 1990
HS-1113 HEALING SCREW - REV. A
Minimatic Implant Technology
Dental
127d
Cleared
Nov 13, 1990
PART NUMBER: TA-1118 TAP
Minimatic Implant Technology
Dental
123d
Cleared
Nov 13, 1990
PP-1105 PARALLEL PIN
Minimatic Implant Technology
Dental
123d
Cleared
Nov 13, 1990
DG-1109 DEPTH GAGE
Minimatic Implant Technology
Dental
123d