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
1249–1272 of 1550
Cleared Apr 28, 1995
DYNA IMPLANT DESIGN
K930868
Dyna Dental Engineering BV
Dental · 798d
Cleared Apr 26, 1995
KIS-II STR FIXTURES
K944725
Implant Center of the Palm Beaches
Dental · 212d
Cleared Apr 20, 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950936
Steri-Oss, Inc.
Dental · 50d
Cleared Apr 14, 1995
STERI-OSS SCALER FOR DENTAL IMPLANTS
K943681
Steri-Oss, Inc.
Dental · 262d
Cleared Apr 13, 1995
BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
K945398
Nobelpharma USA, Inc.
Dental · 161d
Cleared Mar 31, 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
K951111
Lifecore Biomedical, Inc.
Dental · 21d
Cleared Mar 29, 1995
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT
K944158
Steri-Oss, Inc.
Dental · 215d
Cleared Mar 24, 1995
ITI TRANSVERSAL SCREWING SYSTEM
K943720
The Straumann Co.
Dental · 235d
Cleared Mar 13, 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION
K935544
Implant Innovations International, Inc.
Dental · 486d
Cleared Mar 13, 1995
OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL
K944943
Opti-Max
Dental · 157d
Cleared Mar 08, 1995
BRANEMARK SYSTEM 3.3MM FIXTURE
K944683
Nobelpharma USA, Inc.
Dental · 167d
Cleared Mar 01, 1995
KIS-II IMPLANT FIXTURES
K943971
Implant Center of the Palm Beaches
Dental · 198d
Cleared Mar 01, 1995
KIS-II NON-ANGULATED ABUTMENTS
K943984
Implant Center of the Palm Beaches
Dental · 197d
Cleared Mar 01, 1995
IMPLANT BODY RETRIEVER/REMOVER
K946113
"O" Co., Inc.
Dental · 76d
Cleared Mar 01, 1995
IMPLANT BODY DEPTH GAUGE/TRYIN
K946129
"O" Co., Inc.
Dental · 75d
Cleared Feb 28, 1995
RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K944069
Lifecore Biomedical, Inc.
Dental · 194d
Cleared Feb 28, 1995
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
K944964
Nobelpharma USA, Inc.
Dental · 144d
Cleared Feb 27, 1995
BRANEMARK SYSTEM 17 ANGULATED ABUTMENT
K944962
Nobelpharma USA, Inc.
Dental · 143d
Cleared Feb 17, 1995
BRANEMARK SYSTEM SMILINE II
K944963
Nobelpharma USA, Inc.
Dental · 133d
Cleared Feb 16, 1995
PARRALLEL PIN
K944904
"O" Co., Inc.
Dental · 134d
Cleared Feb 16, 1995
ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT
K945300
"O" Co., Inc.
Dental · 108d
Cleared Feb 13, 1995
ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K926354
Innova Corp.
Dental · 784d
Cleared Feb 02, 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)
K944068
Lifecore Biomedical, Inc.
Dental · 171d
Cleared Dec 05, 1994
KIS-II IMPLANT SYSTEM/DRILLS
K944356
Implant Center of the Palm Beaches
Dental · 111d