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
697–720 of 1550
Cleared Feb 14, 2008
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
K080074
Ace Surgical Supply Co., Inc.
Dental · 34d
Cleared Feb 08, 2008
BIOHORIZONS INTERNAL IMPLANT SYSTEM
K073268
BioHorizons Implant Systems, Inc.
Dental · 80d
Cleared Feb 06, 2008
ATLAS IMPLANT SYSTEM
K071148
Cowellmedi Co., Ltd.
Dental · 288d
Cleared Feb 04, 2008
MS SYSTEM (DENTURE)
K072959
Osstem Implant Co., Ltd.
Dental · 108d
Cleared Jan 31, 2008
NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
K072363
Biomet 3i, Inc.
Dental · 161d
Cleared Jan 24, 2008
IMPLASA-HOECHST GMBH IMPLANTS
K071240
Implasa-Hoechst GmbH
Dental · 266d
Cleared Jan 14, 2008
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM
K072917
Odontit S.A.
Dental · 94d
Cleared Jan 11, 2008
NOBELREPLACE HEXAGONAL IMPLANT
K073142
Nobel Biocare USA, LLC
Dental · 65d
Cleared Jan 10, 2008
MS SYSTEM (PROVISIONAL)
K072871
Osstem Implant Co., Ltd.
Dental · 93d
Cleared Dec 28, 2007
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
K070857
Nobel Biocare AB
Dental · 275d
Cleared Dec 20, 2007
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
K072980
Nobel Biocare AB
Dental · 58d
Cleared Dec 13, 2007
SCREWPLUS DENTAL IMPLANTS (HA)
K073049
Implant Direct, LLC
Dental · 45d
Cleared Dec 12, 2007
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
K072660
Imtec Corp.
Dental · 82d
Cleared Dec 10, 2007
LEGACY DENTAL IMPLANTS
K073033
Implant Direct, LLC
Dental · 45d
Cleared Dec 06, 2007
SPI SYSTEM DENTAL IMPLANTS
K072649
Thommen Medical AG
Dental · 78d
Cleared Nov 28, 2007
IMPLUS IMPLANT SYSTEM
K062931
Leader Italia S.R.L.
Dental · 426d
Cleared Nov 16, 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K071161
Southern Implants, Inc.
Dental · 204d
Cleared Nov 15, 2007
SPI CONTACT PLATFORM O 4.0 MM
K072933
Thommen Medical AG
Dental · 30d
Cleared Nov 09, 2007
T.B.R. ZIRCONNECT
K070935
Sudimplant SA
Dental · 220d
Cleared Nov 08, 2007
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
K070569
Dio Department Dsi, Inc.
Dental · 253d
Cleared Nov 06, 2007
GS FIXTURE SYSTEM
K072896
Osstem Implant Co., Ltd.
Dental · 26d
Cleared Oct 29, 2007
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX
K062542
Z-Systems AG
Dental · 425d
Cleared Oct 23, 2007
OLYMPUS DENTAL IMPLANT SYSTEM
K071070
Keystone Dental, Inc.
Dental · 190d
Cleared Oct 23, 2007
RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
K072768
Lifecore Biomedical, Inc.
Dental · 25d