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
1153–1176 of 1550
Cleared Mar 15, 1996
KIS MT5
K960112
The Implant Center of the Palm Beaches
Dental · 64d
Cleared Mar 08, 1996
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K955619
Calcitek, Inc.
Dental · 88d
Cleared Mar 08, 1996
INTERPORE THREADED IMPLANT
K960371
Interpore Intl.
Dental · 42d
Cleared Mar 05, 1996
PHOENIX 4.0 MM HA COATED DENTAL IMPLANT
K931647
Vancouver Implant Center
Dental · 1065d
Cleared Feb 23, 1996
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K954512
Lifecore Biomedical, Inc.
Dental · 148d
Cleared Feb 09, 1996
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955427
Implant Innovations, Inc.
Dental · 73d
Cleared Feb 08, 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943604
Calcitek, Inc.
Dental · 563d
Cleared Feb 08, 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428
Implant Innovations, Inc.
Dental · 72d
Cleared Feb 08, 1996
CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K960021
Calcitek, Inc.
Dental · 37d
Cleared Jan 30, 1996
INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT
K955492
Interpore Intl.
Dental · 60d
Cleared Jan 30, 1996
ABUTMENT RETRIEVAL KIT
K955697
Nobelpharma USA, Inc.
Dental · 47d
Cleared Jan 23, 1996
BALL ATTACHMENT SYSTEM
K955372
Nobelpharma USA, Inc.
Dental · 62d
Cleared Jan 11, 1996
RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM
K954819
Lifecore Biomedical, Inc.
Dental · 83d
Cleared Jan 11, 1996
RESTORE HA DENTAL IMPLANT SYSTEM
K954865
Lifecore Biomedical, Inc.
Dental · 80d
Cleared Jan 11, 1996
KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
K955048
The Implant Center of the Palm Beaches
Dental · 69d
Cleared Jan 04, 1996
CAL-FORM DENTAL IMPLANTS
K933646
Cal-Form, Inc.
Dental · 891d
Cleared Dec 21, 1995
PARAGON IMPLANT SYSTEM
K953101
Core-Vent Bio-Engineering, Inc.
Dental · 171d
Cleared Dec 19, 1995
KIS II LG HEX SCREW & CYLINDER IMPLANTS
K953558
The Implant Center of the Palm Beaches
Dental · 154d
Cleared Nov 15, 1995
INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946319
Calcitek, Inc.
Dental · 322d
Cleared Nov 15, 1995
INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946345
Calcitek, Inc.
Dental · 320d
Cleared Nov 08, 1995
SCREW IMPLANTS, GRADE 3
K953234
The Implant Center of the Palm Beaches
Dental · 120d
Cleared Oct 31, 1995
WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS
K952985
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
WIDE SCREW HA-5B, CYL-HA-5
K952991
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
PROSTHETICS 4MM
K952992
Implant Center of the Palm Beaches
Dental · 130d