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
Mar 15, 1996
KIS MT5
The Implant Center of the Palm Beaches
Dental
64d
Cleared
Mar 08, 1996
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
Calcitek, Inc.
Dental
88d
Cleared
Mar 08, 1996
INTERPORE THREADED IMPLANT
Interpore Intl.
Dental
42d
Cleared
Mar 05, 1996
PHOENIX 4.0 MM HA COATED DENTAL IMPLANT
Vancouver Implant Center
Dental
1065d
Cleared
Feb 23, 1996
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
Lifecore Biomedical, Inc.
Dental
148d
Cleared
Feb 09, 1996
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
Implant Innovations, Inc.
Dental
73d
Cleared
Feb 08, 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
Calcitek, Inc.
Dental
563d
Cleared
Feb 08, 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
Implant Innovations, Inc.
Dental
72d
Cleared
Feb 08, 1996
CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS
Calcitek, Inc.
Dental
37d
Cleared
Jan 30, 1996
INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT
Interpore Intl.
Dental
60d
Cleared
Jan 30, 1996
ABUTMENT RETRIEVAL KIT
Nobelpharma USA, Inc.
Dental
47d
Cleared
Jan 23, 1996
BALL ATTACHMENT SYSTEM
Nobelpharma USA, Inc.
Dental
62d
Cleared
Jan 11, 1996
RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM
Lifecore Biomedical, Inc.
Dental
83d
Cleared
Jan 11, 1996
RESTORE HA DENTAL IMPLANT SYSTEM
Lifecore Biomedical, Inc.
Dental
80d
Cleared
Jan 11, 1996
KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
The Implant Center of the Palm Beaches
Dental
69d
Cleared
Jan 04, 1996
CAL-FORM DENTAL IMPLANTS
Cal-Form, Inc.
Dental
891d
Cleared
Dec 21, 1995
PARAGON IMPLANT SYSTEM
Core-Vent Bio-Engineering, Inc.
Dental
171d
Cleared
Dec 19, 1995
KIS II LG HEX SCREW & CYLINDER IMPLANTS
The Implant Center of the Palm Beaches
Dental
154d
Cleared
Nov 15, 1995
INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
Calcitek, Inc.
Dental
322d
Cleared
Nov 15, 1995
INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
Calcitek, Inc.
Dental
320d
Cleared
Nov 08, 1995
SCREW IMPLANTS, GRADE 3
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
Implant Center of the Palm Beaches
Dental
130d
Cleared
Oct 31, 1995
WIDE SCREW HA-5B, CYL-HA-5
Implant Center of the Palm Beaches
Dental
130d
Cleared
Oct 31, 1995
PROSTHETICS 4MM
Implant Center of the Palm Beaches
Dental
130d