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
553–576 of 713
Cleared Feb 14, 2008
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT
K073258
Atlantis Components, Inc.
Dental · 86d
Cleared Feb 12, 2008
ANKYLOS TEMPORARY ABUTMENT BALANCE
K073073
Dentsply International, Inc.
Dental · 104d
Cleared Jan 22, 2008
SYNOCTA ABUTMENTS
K073628
Straumann USA
Dental · 27d
Cleared Dec 28, 2007
NOBELACTIVE MULTI UNIT ABUTMENT
K072570
Nobel Biocare AB
Dental · 107d
Cleared Dec 05, 2007
SPI ART ABUTMENT
K073141
Thommen Medical AG
Dental · 28d
Cleared Nov 20, 2007
IMPLANTIUM PROSTHETICS
K070228
Dentium Co., Ltd.
Dental · 300d
Cleared Nov 16, 2007
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
K072483
Atlantis Components, Inc.
Dental · 73d
Cleared Nov 16, 2007
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
K073032
Lifecore Biomedical, Inc.
Dental · 21d
Cleared Nov 09, 2007
PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
K072241
Lifecore Biomedical, Inc.
Dental · 88d
Cleared Oct 15, 2007
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
K071888
Straumann USA
Dental · 98d
Cleared Oct 12, 2007
P.004 ABUTMENTS
K072679
Institut Straumann AG
Dental · 21d
Cleared Oct 05, 2007
ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
K071946
Atlantis Components, Inc.
Dental · 84d
Cleared Oct 05, 2007
PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS
K072572
Lifecore Biomedical, Inc.
Dental · 23d
Cleared Sep 26, 2007
P.004 NC ANATOMIC ABUTMENTS
K071357
Institut Straumann AG
Dental · 134d
Cleared Sep 26, 2007
P.004 NC GOLD ABUTMENT FOR CROWNS
K072497
Institut Straumann AG
Dental · 21d
Cleared Sep 19, 2007
SPI EASY 4.0 ABUTMENT
K071453
Thommen Medical AG
Dental · 117d
Cleared Sep 11, 2007
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
K072151
Straumann USA
Dental · 39d
Cleared Aug 31, 2007
STRAUMANN P.004 RC GOLD ABUTMENT
K070549
Institut Straumann AG
Dental · 186d
Cleared Aug 15, 2007
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
K072071
Institut Straumann AG
Dental · 16d
Cleared Jul 11, 2007
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
K071585
Straumann USA
Dental · 30d
Cleared Jun 29, 2007
NARROW NECK TEMPORARY COPING
K070744
Institut Straumann AG
Dental · 105d
Cleared Jun 27, 2007
TITANIUM SCALLOPED ABUTMENT
K063768
Vident
Dental · 189d
Cleared Jun 22, 2007
ATLANTIS ABUTMENT FOR ASTRA IMPLANT
K070833
Atlantis Components, Inc.
Dental · 87d
Cleared May 10, 2007
WN SYNOCTA GOLD ABUTMENT
K063789
Straumann USA
Dental · 140d