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
793–816 of 1550
Cleared Dec 08, 2005
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K052490
Northern Implants, LLC
Dental · 87d
Cleared Dec 02, 2005
BIOHORIZONS SINGLE-STAGE IMPLANT
K053152
BioHorizons Implant Systems, Inc.
Dental · 22d
Cleared Oct 21, 2005
MODUS IMF SCREWS 2.0
K052061
Medartis, Inc.
Dental · 84d
Cleared Oct 14, 2005
MILO DENTAL IMPLANT SYSTEM
K050970
Intra-Lock International
Dental · 179d
Cleared Sep 23, 2005
SISTEMA DE IMPLANTE NACIONAL (S.I.N.)
K051859
Sin Sistema DE Implante Nacional Ltda
Dental · 77d
Cleared Sep 20, 2005
MAXIMUS 3.0 AND OS IMPLANTS
K052419
BioHorizons Implant Systems, Inc.
Dental · 18d
Cleared Sep 19, 2005
O.A.S.I. SYSTEM
K051552
Lancer Orthodontics, Inc.
Dental · 98d
Cleared Sep 15, 2005
3I OSSEOTITE DENTAL IMPLANTS
K051461
Implant Innovations, Inc.
Dental · 104d
Cleared Sep 09, 2005
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
K051614
Lifecore Biomedical, Inc.
Dental · 84d
Cleared Sep 02, 2005
INTERMEZZO IMPLANT SYSTEMS
K051018
Megagen Co., Ltd.
Dental · 134d
Cleared Sep 02, 2005
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
K051507
Blue Sky Bio, LLC
Dental · 87d
Cleared Sep 01, 2005
AVANA DENTAL IMPLANT SYSTEM
K051576
Osstem Co., Ltd.
Dental · 79d
Cleared Jul 28, 2005
ALLFIM IMPLANT SYSTEMS
K050635
Cowellmedi Co., Ltd.
Dental · 119d
Cleared Jun 21, 2005
SPI DENTAL IMPLANT
K051502
Thommen Medical AG
Dental · 14d
Cleared Jun 15, 2005
MEDICON IMF-ORION SCREWS
K050478
Medicon EG
Dental · 111d
Cleared Jun 08, 2005
NOBELSPEEDY IMPLANTS
K050406
Nobel Biocare AB
Dental · 111d
Cleared Jun 08, 2005
PREVAIL DENTAL IMPLANTS
K051189
Implant Innovations, Inc.
Dental · 29d
Cleared Jun 01, 2005
ORLUS MINI SCREW
K050568
Ortholution Co., Ltd.
Dental · 89d
Cleared May 19, 2005
TIUNITE IMPLANTS
K050705
Nobel Biocare AB
Dental · 62d
Cleared May 04, 2005
THE GUIDED SURGERY CONCEPT
K050393
Nobel Biocare AB
Dental · 77d
Cleared Apr 22, 2005
4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
K050712
Bicon, Inc.
Dental · 36d
Cleared Apr 19, 2005
GROOVY IMPLANTS
K050258
Nobel Biocare AB
Dental · 75d
Cleared Apr 15, 2005
PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS
K050506
Lifecore Biomedical, Inc.
Dental · 46d
Cleared Apr 13, 2005
SIC PRO
K040757
Sic Invent AG
Dental · 384d