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
Cleared
Aug 27, 2003
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
Straumann USA
Dental
14d
Cleared
Jul 02, 2003
ESTHETIC ZIRCONIA ABUTMENT
Nobel Biocare AB
Dental
29d
Cleared
Aug 30, 2002
MODIFICATION TO THE MAESTRO SYSTEM
BioHorizons Implant Systems, Inc.
Dental
7d
Cleared
Jul 03, 1997
BIO-ESTHETIC INDIRECT ABUTMENT
Steri-Oss, Inc.
Dental
176d
Cleared
Jul 18, 1996
17 ANGULATED ABUTMENT
Nobelpharma USA, Inc.
Dental
76d
Cleared
Jul 10, 1996
MIRUSCONE ABUTMENT SYSTEM
Nobelpharma USA, Inc.
Dental
68d
Cleared
Apr 20, 1993
BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS
Nobelpharma USA, Inc.
Dental
155d
Cleared
Apr 14, 1993
BRANEMARK SYSTEM ABUTMENTS COMPLETE
Nobelpharma USA, Inc.
Dental
149d