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
Jul 24, 2002
ENDOSSOUS IMPLANTS
Intra-Lock International
Dental
90d
Cleared
Jul 15, 2002
SPI ONETIME DENTAL IMPLANT
Paxmed International
Dental
21d
Cleared
Jul 02, 2002
XIVE DENTAL IMPLANT SYSTEM
Friadent GmbH
Dental
68d
Cleared
Jun 26, 2002
ERA IMPLANT
Sterngold
Dental
86d
Cleared
Jun 10, 2002
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
Blue Sky Bio
Dental
6d
Cleared
Jun 05, 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
Nobel Biocare Uas, Inc.
Dental
22d
Cleared
Jun 04, 2002
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
SOADCO, S.L.
Dental
504d
Cleared
May 29, 2002
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
Nobel Biocare Uas, Inc.
Dental
90d
Cleared
May 16, 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
Implant Innovations, Inc.
Dental
141d
Cleared
May 10, 2002
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
Nsi
Dental
74d
Cleared
May 03, 2002
ACE HA SCREW DENTAL IMPLANT SYSTEM
Ace Surgical Supply Co., Inc.
Dental
14d
Cleared
Apr 10, 2002
IMMEDIATE STABILIZING DEVICE (ISD)
"O" Co., Inc.
Dental
328d
Cleared
Apr 09, 2002
FRIALOC DENTAL IMPLANT SYSTEM
Friadent GmbH
Dental
209d
Cleared
Mar 19, 2002
SULZER DENTAL CERAMIC SYSTEM-SPLINE
Sulzer Dental, Inc.
Dental
88d
Cleared
Mar 15, 2002
XIVE DENTAL IMPLANT SYSTEM
Friadent GmbH
Dental
114d
Cleared
Mar 15, 2002
MODIFICATION TO THE MAESTRO SYSTEM
BioHorizons Implant Systems, Inc.
Dental
15d
Cleared
Mar 08, 2002
STERN MICRO ERA ATTACHMENT SYSTEM
Sterngold
Dental
30d
Cleared
Mar 04, 2002
O-RING PROSTHETIC ATTACHMENT
Titan Implants
Dental
643d
Cleared
Feb 08, 2002
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
Institut Straumann AG
Dental
28d
Cleared
Feb 05, 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
Institut Straumann AG
Dental
74d
Cleared
Jan 25, 2002
MODIFICATION TO THE MAESTRO SYSTEM
BioHorizons Implant Systems, Inc.
Dental
10d
Cleared
Jan 18, 2002
3.75MM AND 5.0MM SPLINE TWIST IMPLANT
Sulzer Dental, Inc.
Dental
88d
Cleared
Jan 10, 2002
BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
Biomedical Implant Technology, Inc.
Dental
90d
Cleared
Dec 20, 2001
FRIALIT-2 ESTHETICBASE ABUTMENT
Friadent GmbH
Dental
64d