DZE · Class II · 21 CFR 872.3640

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
1417–1440 of 1550
Cleared Feb 19, 1991
CORE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900180
Core-Vent Corp.
Dental · 399d
Cleared Feb 11, 1991
CASTABLE ABUTMENTS
K900694
Calcitek, Inc.
Dental · 363d
Cleared Feb 05, 1991
INTERPORE CYLINDRICAL HEX IMPLANT
K904611
Interpore Intl.
Dental · 117d
Cleared Jan 29, 1991
DEVICE PART NUMBER DPI-1106 IMPLANT
K902928
Minimatic Implant Technology
Dental · 210d
Cleared Jan 29, 1991
TITANIUM COC ABUTMENT HEADS FOR IMZ
K904605
Implant Support Systems, Inc.
Dental · 111d
Cleared Jan 15, 1991
THE O-RING SYSTEM - ORS
K900099
Attachments Intl., Inc.
Dental · 372d
Cleared Jan 14, 1991
BC 1220 ANALOG - IMPLANT BODY
K904711
Minimatic Implant Technology
Dental · 90d
Cleared Jan 04, 1991
HA-TI (HAND-TITANIUM SCREW) IMPLANT
K901927
Mathys Corp. of North America
Dental · 249d
Cleared Dec 27, 1990
CGA-112 COPING GOLD ALLOY
K903113
Minimatic Implant Technology
Dental · 167d
Cleared Dec 26, 1990
A-1101 CAST ABUTMENT
K903039
Minimatic Implant Technology
Dental · 168d
Cleared Dec 17, 1990
SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
K902969
Core-Vent Corp.
Dental · 164d
Cleared Nov 30, 1990
A-1107 ABUTMENT (FIXED)
K903041
Minimatic Implant Technology
Dental · 142d
Cleared Nov 26, 1990
A-1103 ABUTMENT (REMOVABLE)
K903040
Minimatic Implant Technology
Dental · 138d
Cleared Nov 20, 1990
DEVICE PART NUMBER: SVD-3S DRILL
K902930
Minimatic Implant Technology
Dental · 138d
Cleared Nov 20, 1990
TC-1111 TRANSFER PIN
K903044
Minimatic Implant Technology
Dental · 132d
Cleared Nov 20, 1990
ABO-1122 ANALOG BALL OVERDENTURE
K903518
Minimatic Implant Technology
Dental · 109d
Cleared Nov 20, 1990
SATC-1114, SHOULDER ABUTMENT TRANSFER COPING
K904460
Minimatic Implant Technology
Dental · 50d
Cleared Nov 13, 1990
DEVICE PART NUMBER SVD2, 3, 4 SPADE DRILL
K902929
Minimatic Implant Technology
Dental · 133d
Cleared Nov 13, 1990
DEVICE PART NUMBER: PD-12 PILOT DRILL
K902931
Minimatic Implant Technology
Dental · 131d
Cleared Nov 13, 1990
AA-1110 ANALOG ABUTMENT
K903042
Minimatic Implant Technology
Dental · 125d
Cleared Nov 13, 1990
HS-1113 HEALING SCREW - REV. A
K903062
Minimatic Implant Technology
Dental · 127d
Cleared Nov 13, 1990
PART NUMBER: TA-1118 TAP
K903112
Minimatic Implant Technology
Dental · 123d
Cleared Nov 13, 1990
PP-1105 PARALLEL PIN
K903114
Minimatic Implant Technology
Dental · 123d
Cleared Nov 13, 1990
DG-1109 DEPTH GAGE
K903115
Minimatic Implant Technology
Dental · 123d