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
Feb 14, 2008
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT
Atlantis Components, Inc.
Dental
86d
Cleared
Feb 12, 2008
ANKYLOS TEMPORARY ABUTMENT BALANCE
Dentsply International, Inc.
Dental
104d
Cleared
Jan 22, 2008
SYNOCTA ABUTMENTS
Straumann USA
Dental
27d
Cleared
Dec 28, 2007
NOBELACTIVE MULTI UNIT ABUTMENT
Nobel Biocare AB
Dental
107d
Cleared
Dec 05, 2007
SPI ART ABUTMENT
Thommen Medical AG
Dental
28d
Cleared
Nov 20, 2007
IMPLANTIUM PROSTHETICS
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
Atlantis Components, Inc.
Dental
73d
Cleared
Nov 16, 2007
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
Lifecore Biomedical, Inc.
Dental
21d
Cleared
Nov 09, 2007
PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
Lifecore Biomedical, Inc.
Dental
88d
Cleared
Oct 15, 2007
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
Straumann USA
Dental
98d
Cleared
Oct 12, 2007
P.004 ABUTMENTS
Institut Straumann AG
Dental
21d
Cleared
Oct 05, 2007
ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
Atlantis Components, Inc.
Dental
84d
Cleared
Oct 05, 2007
PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS
Lifecore Biomedical, Inc.
Dental
23d
Cleared
Sep 26, 2007
P.004 NC ANATOMIC ABUTMENTS
Institut Straumann AG
Dental
134d
Cleared
Sep 26, 2007
P.004 NC GOLD ABUTMENT FOR CROWNS
Institut Straumann AG
Dental
21d
Cleared
Sep 19, 2007
SPI EASY 4.0 ABUTMENT
Thommen Medical AG
Dental
117d
Cleared
Sep 11, 2007
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
Straumann USA
Dental
39d
Cleared
Aug 31, 2007
STRAUMANN P.004 RC GOLD ABUTMENT
Institut Straumann AG
Dental
186d
Cleared
Aug 15, 2007
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
Institut Straumann AG
Dental
16d
Cleared
Jul 11, 2007
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
Straumann USA
Dental
30d
Cleared
Jun 29, 2007
NARROW NECK TEMPORARY COPING
Institut Straumann AG
Dental
105d
Cleared
Jun 27, 2007
TITANIUM SCALLOPED ABUTMENT
Vident
Dental
189d
Cleared
Jun 22, 2007
ATLANTIS ABUTMENT FOR ASTRA IMPLANT
Atlantis Components, Inc.
Dental
87d
Cleared
May 10, 2007
WN SYNOCTA GOLD ABUTMENT
Straumann USA
Dental
140d