NHA · Class II · 21 CFR 872.3630

FDA Product Code NHA: Abutment, Implant, Dental, Endosseous

FDA product code NHA covers dental implant abutments.

These components connect the endosseous implant fixture to the prosthetic restoration — such as a crown, bridge, or denture. They are designed to emerge through the gum tissue and provide a stable foundation for the final prosthesis.

NHA devices are Class II medical devices, regulated under 21 CFR 872.3630 and reviewed by the FDA Dental panel.

Leading manufacturers include Institut Straumann AG, Nobel Biocare AB and Zimmer Dental, Inc..

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
577–600 of 713
Cleared Apr 12, 2007
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
K061277
Straumann USA
Dental · 339d
Cleared Mar 20, 2007
CONICAL ANGLED ABUTMENT
K063403
Implant Innovations, Inc.
Dental · 131d
Cleared Mar 02, 2007
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE
K063734
Atlantis Components, Inc.
Dental · 74d
Cleared Feb 28, 2007
ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI
K062197
Atlantis Components, Inc.
Dental · 211d
Cleared Feb 27, 2007
ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554
K063592
Nobel Biocare AB
Dental · 85d
Cleared Feb 14, 2007
ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT
K062069
Atlantis Components, Inc.
Dental · 208d
Cleared Dec 20, 2006
ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE
K062277
Atlantis Components, Inc.
Dental · 135d
Cleared Nov 29, 2006
SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM
K062749
Nobel Biocare AB
Dental · 76d
Cleared Nov 22, 2006
BIOHORIZONS CERAMIC ABUTMENT
K061567
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Nov 17, 2006
LAVA SOFTWARE
K062493
3M Espe AG Dental Products
Dental · 84d
Cleared Nov 01, 2006
PRIMACONNEX CERAMIC ABUTMENTS
K062876
Lifecore Biomedical, Inc.
Dental · 36d
Cleared Oct 12, 2006
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S
K061847
Zimmer Dental, Inc.
Dental · 104d
Cleared Aug 23, 2006
PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM
K061529
Nobel Biocare AB
Dental · 82d
Cleared Aug 21, 2006
PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS
K061478
Nobel Biocare AB
Dental · 83d
Cleared Aug 11, 2006
MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS
K061477
Nobel Biocare AB
Dental · 73d
Cleared Jul 31, 2006
ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE
K053654
Atlantis Components, Inc.
Dental · 213d
Cleared Jul 31, 2006
SPI ART ABUTMENTS
K061807
Thommen Medical AG
Dental · 34d
Cleared Jul 27, 2006
IMPLANTIUM PROSTHETICS
K052957
Dentium Co., Ltd.
Dental · 279d
Cleared Jul 21, 2006
PREFORMANCE POSTS AND TEMPORARY CYLINDERS
K061969
Implant Innovations, Inc.
Dental · 9d
Cleared Jun 30, 2006
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
K053373
Atlantis Components, Inc.
Dental · 207d
Cleared Jun 27, 2006
ZIMMER CONTOUR RESTORATIVE SYSTEM
K061043
Zimmer Dental, Inc.
Dental · 74d
Cleared May 17, 2006
ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1
K060880
Zimmer Dental, Inc.
Dental · 47d
Cleared May 16, 2006
PROVIDE TEMPORARY CYLINDER
K061177
Implant Innovations, Inc.
Dental · 19d
Cleared Mar 03, 2006
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
K053450
Atlantis Components, Inc.
Dental · 81d