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
745–768 of 1550
Cleared Feb 22, 2007
NANOTITE DENTAL IMPLANTS
K062432
Implant Innovations, Inc.
Dental · 185d
Cleared Feb 16, 2007
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16
K063523
Zimmer Dental, Inc.
Dental · 86d
Cleared Jan 10, 2007
SPI ELEMENT PLATFORM O 4.0 MM
K070007
Thommen Medical AG
Dental · 7d
Cleared Jan 05, 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
K063718
Nobel Biocare AB
Dental · 22d
Cleared Dec 19, 2006
NOBELPERFECT CONICAL CONNECTION
K062936
Nobel Biocare AB
Dental · 82d
Cleared Dec 08, 2006
MINISCREWS ANCHORING SYSTEM, M.A.S.
K062367
Micerium S.P.A.
Dental · 116d
Cleared Dec 06, 2006
NOBELREPLACE TAPERED CONICAL CONNECTION
K062566
Nobel Biocare USA, LLC
Dental · 97d
Cleared Nov 21, 2006
THE 5.0 X 6.0MM DENTAL IMPLANT
K062044
Bicon, Inc.
Dental · 125d
Cleared Nov 02, 2006
US SYSTEM
K062030
Osstem Implant Co., Ltd.
Dental · 107d
Cleared Nov 01, 2006
SS SYSTEM
K062051
Osstem Implant Co., Ltd.
Dental · 105d
Cleared Oct 20, 2006
P.0004 IMPLANTS
K062129
Institut Straumann AG
Dental · 86d
Cleared Oct 20, 2006
SUPER ORTHODONTIC SCREW
K062156
Osstem Implant Co., Ltd.
Dental · 84d
Cleared Sep 29, 2006
SPECTRA SYSTEM
K061319
Implant Direct, LLC
Dental · 141d
Cleared Sep 08, 2006
MODIFICATION TO: ORLUS MINI SCREW
K052968
Ortholution Co., Ltd.
Dental · 322d
Cleared Sep 08, 2006
SCREW-VENT IMPLANT SYSTEM, SV
K061410
Zimmer Dental, Inc.
Dental · 109d
Cleared Sep 08, 2006
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
K061717
Zimmer Dental, Inc.
Dental · 81d
Cleared Sep 05, 2006
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
K062281
Zimmer Dental, Inc.
Dental · 29d
Cleared Sep 01, 2006
SM IMPLANT SYSTEMS
K061797
Dio Department Dsi, Inc.
Dental · 67d
Cleared Aug 24, 2006
STRAUMANN NARROW NECK IMPLANTS
K060958
Straumann USA
Dental · 139d
Cleared Aug 11, 2006
STRAUMANN DENTAL IMPLANTS
K061176
Institut Straumann AG
Dental · 106d
Cleared Aug 09, 2006
ENHANCE DENTAL IMPLANT SYSTEM
K061335
Coastal Biocare
Dental · 89d
Cleared Aug 08, 2006
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
K061500
Sic Invent AG
Dental · 69d
Cleared Jun 30, 2006
SFB & CFB IMPLANTS
K061003
Nobel Biocare AB
Dental · 80d
Cleared Jun 20, 2006
ENDOSSEOUS DENTAL IMPLANT
K061169
Northern Implants, LLC
Dental · 54d