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..

712
Total
712
Cleared
169d
Avg days
1993
Since
712 devices
433–456 of 712
Cleared Aug 23, 2006
PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM
K061529
Nobel Biocare AB
Dental · 82d
Cleared Aug 21, 2006
PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS
K061478
Nobel Biocare AB
Dental · 83d
Cleared Aug 11, 2006
MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS
K061477
Nobel Biocare AB
Dental · 73d
Cleared Jul 21, 2006
PREFORMANCE POSTS AND TEMPORARY CYLINDERS
K061969
Implant Innovations, Inc.
Dental · 9d
Cleared Jun 27, 2006
ZIMMER CONTOUR RESTORATIVE SYSTEM
K061043
Zimmer Dental, Inc.
Dental · 74d
Cleared May 17, 2006
ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1
K060880
Zimmer Dental, Inc.
Dental · 47d
Cleared May 16, 2006
PROVIDE TEMPORARY CYLINDER
K061177
Implant Innovations, Inc.
Dental · 19d
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 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 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 13, 2005
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
K052600
Zimmer Dental, Inc.
Dental · 22d
Cleared Nov 18, 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K043042
Nobel Biocare AB
Dental · 14d
Cleared May 26, 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K041236
Nobel Biocare AB
Dental · 15d
Cleared May 24, 2004
RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
K041295
Institut Straumann AG
Dental · 10d
Cleared Mar 24, 2004
3I PATIENT-SPECIFIC OVERDENTURE BAR
K034035
Implant Innovations, Inc.
Dental · 86d
Cleared Mar 18, 2004
ELLIPTIC MATRIX
K040539
Institut Straumann AG
Dental · 16d
Cleared Oct 20, 2003
ITI SYNOCTA MESO ABUTMENTS
K033243
Straumann USA
Dental · 13d