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
913–936 of 1550
Cleared Jul 24, 2002
ENDOSSOUS IMPLANTS
K021322
Intra-Lock International
Dental · 90d
Cleared Jul 15, 2002
SPI ONETIME DENTAL IMPLANT
K022038
Paxmed International
Dental · 21d
Cleared Jul 02, 2002
XIVE DENTAL IMPLANT SYSTEM
K021318
Friadent GmbH
Dental · 68d
Cleared Jun 26, 2002
ERA IMPLANT
K021045
Sterngold
Dental · 86d
Cleared Jun 10, 2002
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
K021833
Blue Sky Bio
Dental · 6d
Cleared Jun 05, 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
K021584
Nobel Biocare Uas, Inc.
Dental · 22d
Cleared Jun 04, 2002
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
K010132
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
K020646
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared May 16, 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235
Implant Innovations, Inc.
Dental · 141d
Cleared May 10, 2002
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
K020617
Nsi
Dental · 74d
Cleared May 03, 2002
ACE HA SCREW DENTAL IMPLANT SYSTEM
K021244
Ace Surgical Supply Co., Inc.
Dental · 14d
Cleared Apr 10, 2002
IMMEDIATE STABILIZING DEVICE (ISD)
K011524
"O" Co., Inc.
Dental · 328d
Cleared Apr 09, 2002
FRIALOC DENTAL IMPLANT SYSTEM
K013067
Friadent GmbH
Dental · 209d
Cleared Mar 19, 2002
SULZER DENTAL CERAMIC SYSTEM-SPLINE
K014214
Sulzer Dental, Inc.
Dental · 88d
Cleared Mar 15, 2002
XIVE DENTAL IMPLANT SYSTEM
K013867
Friadent GmbH
Dental · 114d
Cleared Mar 15, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645
BioHorizons Implant Systems, Inc.
Dental · 15d
Cleared Mar 08, 2002
STERN MICRO ERA ATTACHMENT SYSTEM
K020391
Sterngold
Dental · 30d
Cleared Mar 04, 2002
O-RING PROSTHETIC ATTACHMENT
K001638
Titan Implants
Dental · 643d
Cleared Feb 08, 2002
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
K020096
Institut Straumann AG
Dental · 28d
Cleared Feb 05, 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891
Institut Straumann AG
Dental · 74d
Cleared Jan 25, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020133
BioHorizons Implant Systems, Inc.
Dental · 10d
Cleared Jan 18, 2002
3.75MM AND 5.0MM SPLINE TWIST IMPLANT
K013494
Sulzer Dental, Inc.
Dental · 88d
Cleared Jan 10, 2002
BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
K013383
Biomedical Implant Technology, Inc.
Dental · 90d
Cleared Dec 20, 2001
FRIALIT-2 ESTHETICBASE ABUTMENT
K013438
Friadent GmbH
Dental · 64d