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..

1548
Total
1548
Cleared
203d
Avg days
1976
Since
1548 devices
937–960 of 1548
Cleared May 19, 1997
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
K962753
Biomedical Implant Technology, Inc.
Dental · 308d
Cleared May 12, 1997
ODONT HEX SYSTEM
K961631
Odontit S.A.
Dental · 378d
Cleared May 08, 1997
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K971196
Innova Corp.
Dental · 38d
Cleared Apr 16, 1997
MINIMATIC VARIOUS IMPLANT SYSTEMS
K952905
Minimatic, Inc.
Dental · 664d
Cleared Apr 11, 1997
LEIBINGER IMF SCREW
K963030
Howmedica Leibinger, Inc.
Dental · 249d
Cleared Mar 31, 1997
STERI-OSS TIODIZED SCREW
K964739
Steri-Oss, Inc.
Dental · 125d
Cleared Mar 17, 1997
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS
K965077
Implant Innovations, Inc.
Dental · 90d
Cleared Mar 05, 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220
Steri-Oss, Inc.
Dental · 134d
Cleared Mar 04, 1997
DENTSPLY PRECISION TORQUE SYSTEM
K964046
Dentsply Intl.
Dental · 146d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM
K963495
Imz, GmbH
Dental · 181d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - SCREW
K963522
Imz, GmbH
Dental · 181d
Cleared Feb 25, 1997
THREADLOC DENTAL IMPLANT SYSTEMS
K964768
Sulzer Calcitek, Inc.
Dental · 90d
Cleared Feb 25, 1997
LIFECORE CONICAL ABUTMENT
K965135
Lifecore Biomedical, Inc.
Dental · 64d
Cleared Feb 11, 1997
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945
Steri-Oss, Inc.
Dental · 132d
Cleared Feb 10, 1997
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
K962576
Calcitek, Inc.
Dental · 224d
Cleared Feb 10, 1997
ROUND DENTAL BUR
K964944
Steri-Oss, Inc.
Dental · 62d
Cleared Jan 17, 1997
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
K964330
BioHorizons Implant Systems, Inc.
Dental · 78d
Cleared Dec 31, 1996
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
K963951
BioHorizons Implant Systems, Inc.
Dental · 90d
Cleared Nov 15, 1996
O BUTMENT ET IMPLANT
K961665
"O" Co., Inc.
Dental · 199d
Cleared Nov 14, 1996
B.A.S.I.C. DENTAL IMPLANT SYSTEM
K960868
Danlin Products, Inc.
Dental · 255d
Cleared Nov 14, 1996
STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT
K963224
Steri-Oss, Inc.
Dental · 90d
Cleared Nov 05, 1996
FIXTURE MOUNT KIT
K963121
Steri-Oss, Inc.
Dental · 85d
Cleared Nov 05, 1996
TPS APICAL IMPLANT
K963401
Steri-Oss, Inc.
Dental · 68d
Cleared Oct 18, 1996
3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.
K962014
Implant Innovations, Inc.
Dental · 148d