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..

712
Total
712
Cleared
169d
Avg days
1993
Since
712 devices
409–432 of 712
Cleared Mar 27, 2008
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
K072730
Dentsply Intl.
Dental · 183d
Cleared Mar 07, 2008
CEMENTABLE ABUNTMENTS
K080286
Straumann USA
Dental · 32d
Cleared Feb 22, 2008
NOBELACTIVE ZIRCONIA ABUTMENT
K072129
Nobel Biocare AB
Dental · 204d
Cleared Feb 14, 2008
GC AADVA ABUTMENT
K072100
GC America, Inc.
Dental · 198d
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 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 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 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 May 10, 2007
WN SYNOCTA GOLD ABUTMENT
K063789
Straumann USA
Dental · 140d
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 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 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 Oct 12, 2006
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S
K061847
Zimmer Dental, Inc.
Dental · 104d