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
529–552 of 713
Cleared Sep 28, 2009
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL
K091920
Astra Tech, Inc.
Dental · 90d
Cleared Sep 25, 2009
NOBELPROCERA ZI ABUTMENT
K091904
Nobel Biocare AB
Dental · 92d
Cleared Sep 25, 2009
SPI CUSTOMIZABLE GINGIVA FORMER
K092248
Thommen Medical AG
Dental · 59d
Cleared Sep 22, 2009
NOBELPROCERA TI ABUTMENT
K091756
Nobel Biocare AB
Dental · 98d
Cleared May 07, 2009
PROCERA IMPLANT BRIDGE OVERDENTURE
K090069
Nobel Biocare AB
Dental · 115d
Cleared Apr 15, 2009
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE
K083871
Astra Tech, Inc.
Dental · 107d
Cleared Apr 07, 2009
HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
K090723
Zimmer Dental, Inc.
Dental · 29d
Cleared Mar 27, 2009
SPI VARIOMULTI ANGLED ABUTMENT
K090153
Thommen Medical AG
Dental · 64d
Cleared Dec 23, 2008
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
K083474
Zimmer Dental, Inc.
Dental · 29d
Cleared Dec 02, 2008
ZIOCERA & CONVERTIBLE SYSTEM
K081786
Osstem Implant Co., Ltd.
Dental · 161d
Cleared Oct 17, 2008
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
K082545
Institut Straumann AG
Dental · 44d
Cleared Oct 07, 2008
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS
K081666
Astra Tech, Inc.
Dental · 116d
Cleared Oct 01, 2008
STRAUMANN WN CARES TITANIUM ABUTMENT
K082764
Institut Straumann AG
Dental · 9d
Cleared Sep 25, 2008
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
K080164
Zimmer Dental, Inc.
Dental · 246d
Cleared Sep 02, 2008
HU/HS/HG PROSTHETIC SYSTEM
K081575
Osstem Implant Co., Ltd.
Dental · 89d
Cleared May 23, 2008
CONCAVE RN HEALING CAP
K081186
Institut Straumann AG
Dental · 25d
Cleared May 02, 2008
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
K081005
Institut Straumann AG
Dental · 24d
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 29, 2008
ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
K073540
Atlantis Components, Inc.
Dental · 73d
Cleared Feb 26, 2008
LAVA FRAME, LAVA FRAME SHADE
K072055
3M Espe AG Dental Products
Dental · 215d
Cleared Feb 22, 2008
NOBELACTIVE ZIRCONIA ABUTMENT
K072129
Nobel Biocare AB
Dental · 204d
Cleared Feb 15, 2008
SPI VARIOMULTI ABUTMENT
K072856
Thommen Medical AG
Dental · 133d
Cleared Feb 14, 2008
GC AADVA ABUTMENT
K072100
GC America, Inc.
Dental · 198d