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
Cleared
Sep 28, 2009
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL
Astra Tech, Inc.
Dental
90d
Cleared
Sep 25, 2009
NOBELPROCERA ZI ABUTMENT
Nobel Biocare AB
Dental
92d
Cleared
Sep 25, 2009
SPI CUSTOMIZABLE GINGIVA FORMER
Thommen Medical AG
Dental
59d
Cleared
Sep 22, 2009
NOBELPROCERA TI ABUTMENT
Nobel Biocare AB
Dental
98d
Cleared
May 07, 2009
PROCERA IMPLANT BRIDGE OVERDENTURE
Nobel Biocare AB
Dental
115d
Cleared
Apr 15, 2009
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE
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,
Zimmer Dental, Inc.
Dental
29d
Cleared
Mar 27, 2009
SPI VARIOMULTI ANGLED ABUTMENT
Thommen Medical AG
Dental
64d
Cleared
Dec 23, 2008
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
Zimmer Dental, Inc.
Dental
29d
Cleared
Dec 02, 2008
ZIOCERA & CONVERTIBLE SYSTEM
Osstem Implant Co., Ltd.
Dental
161d
Cleared
Oct 17, 2008
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
Institut Straumann AG
Dental
44d
Cleared
Oct 07, 2008
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS
Astra Tech, Inc.
Dental
116d
Cleared
Oct 01, 2008
STRAUMANN WN CARES TITANIUM ABUTMENT
Institut Straumann AG
Dental
9d
Cleared
Sep 25, 2008
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
Zimmer Dental, Inc.
Dental
246d
Cleared
Sep 02, 2008
HU/HS/HG PROSTHETIC SYSTEM
Osstem Implant Co., Ltd.
Dental
89d
Cleared
May 23, 2008
CONCAVE RN HEALING CAP
Institut Straumann AG
Dental
25d
Cleared
May 02, 2008
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
Institut Straumann AG
Dental
24d
Cleared
Mar 27, 2008
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
Dentsply Intl.
Dental
183d
Cleared
Mar 07, 2008
CEMENTABLE ABUNTMENTS
Straumann USA
Dental
32d
Cleared
Feb 29, 2008
ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
Atlantis Components, Inc.
Dental
73d
Cleared
Feb 26, 2008
LAVA FRAME, LAVA FRAME SHADE
3M Espe AG Dental Products
Dental
215d
Cleared
Feb 22, 2008
NOBELACTIVE ZIRCONIA ABUTMENT
Nobel Biocare AB
Dental
204d
Cleared
Feb 15, 2008
SPI VARIOMULTI ABUTMENT
Thommen Medical AG
Dental
133d
Cleared
Feb 14, 2008
GC AADVA ABUTMENT
GC America, Inc.
Dental
198d