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 Terrats Medical SL.

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
601–624 of 713
Cleared Feb 27, 2006
PREFORMANCE TEMPORARY CYLINDER
K060291
Implant Innovations, Inc.
Dental · 21d
Cleared Feb 22, 2006
PROCERA BRIDGE ALUMINA
K053050
Nobel Biocare AB
Dental · 117d
Cleared Feb 22, 2006
PROCERA BRIDGE LAMINATE, MODEL 40-4002
K053068
Nobel Biocare AB
Dental · 113d
Cleared Feb 22, 2006
PROCERA BRIDGE ZIRCONIA
K053125
Nobel Biocare AB
Dental · 107d
Cleared Feb 17, 2006
CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
K051636
Altatec GmbH
Dental · 242d
Cleared Feb 14, 2006
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
K053099
BioHorizons Implant Systems, Inc.
Dental · 103d
Cleared Feb 10, 2006
PROCERA SOFTWARE, MODEL 33145
K053602
Nobel Biocare AB
Dental · 49d
Cleared Feb 01, 2006
PREFORMANCE POSTS
K053170
Implant Innovations, Inc.
Dental · 79d
Cleared Jan 27, 2006
PROCERA IMPLANT BRIDGE ZIRCONIA
K053091
Nobel Biocare AB
Dental · 85d
Cleared Jan 23, 2006
STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
K053643
Lifecore Biomedical, Inc.
Dental · 24d
Cleared Jan 03, 2006
STRAUMANN COMPUTER AIDED RESTORATION SERVICE
K052272
Straumann USA
Dental · 134d
Cleared Oct 20, 2005
MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
K052648
Implant Innovations, Inc.
Dental · 24d
Cleared Oct 19, 2005
ZIRACE
K051501
Acucera, Inc.
Dental · 135d
Cleared Oct 14, 2005
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA
K052070
Atlantis Components, Inc.
Dental · 74d
Cleared Oct 13, 2005
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
K052600
Zimmer Dental, Inc.
Dental · 22d
Cleared Jul 28, 2005
SPI EASY TEMPORARY CAP
K051527
Thommen Medical AG
Dental · 50d
Cleared Jul 22, 2005
ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT
K051652
Atlantis Components, Inc.
Dental · 31d
Cleared Jul 12, 2005
RELIADENT DENTAL IMPLANT SYSTEM
K043428
Bioinfera, Inc.
Dental · 211d
Cleared Jul 12, 2005
ENDOSSEOUS DENTAL IMPLANT ABUTMENT
K051011
Atlantis Components, Inc.
Dental · 82d
Cleared Jul 07, 2005
NOBELREPLACE ADAPTER, MODEL 32412
K050444
Nobel Biocare Uas, Inc.
Dental · 135d
Cleared Jul 07, 2005
RN SYNOCTA TEMPORARY MESO ABUTMENT
K051717
Institut Straumann SA
Dental · 10d
Cleared Jun 14, 2005
FRIADENT ESTHETICAP
K050208
Dentsply International
Dental · 137d
Cleared Apr 07, 2005
ZYGOMA TIUNITE
K050641
Nobel Biocare USA, LLC
Dental · 24d
Cleared Mar 23, 2005
TITAN DENTAL IMPLANT ATTACHMENT
K042715
Titan Implants, Inc.
Dental · 174d