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
361–384 of 712
Cleared Jan 30, 2013
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
K113816
GC America, Inc.
Dental · 400d
Cleared Dec 21, 2012
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST
K120822
Institut Straumann AG
Dental · 277d
Cleared Dec 11, 2012
NP-CAST ABUTMENT SYSTEM
K121843
Osstem Implant Co., Ltd.
Dental · 169d
Cleared Dec 10, 2012
INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
K121391
Prismatik Dentalcraft, Inc.
Dental · 215d
Cleared Dec 06, 2012
IMPLANT BAR
K120858
Prismatik Dentalcraft, Inc.
Dental · 260d
Cleared Nov 08, 2012
ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
K120873
Zimmer Dental, Inc.
Dental · 231d
Cleared Oct 19, 2012
ZFX DENTAL CAD SYSTEM
K121709
Zimmer Dental, Inc.
Dental · 130d
Cleared Oct 12, 2012
MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
K121688
Prismatik Dentalcraft, Inc.
Dental · 127d
Cleared Feb 17, 2012
SIRONA DENTAL CAD/CAM SYSTEM
K111421
Sirona Dental Systems GmbH
Dental · 273d
Cleared Jan 27, 2012
NNC GOLD ABUTMENT FOR BRIDGES
K113606
Straumann USA
Dental · 52d
Cleared Jan 23, 2012
ZIMMER CONTOUR PROVISIONAL COPING
K113092
Zimmer Dental, Inc.
Dental · 96d
Cleared Jan 13, 2012
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
K113410
Straumann USA
Dental · 56d
Cleared Dec 28, 2011
NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS
K113283
Straumann USA
Dental · 51d
Cleared Dec 08, 2011
ANGLED TAPERED ABUTMENT
K111853
Zimmer Dental, Inc.
Dental · 162d
Cleared Nov 16, 2011
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
K112280
Straumann USA
Dental · 99d
Cleared Nov 04, 2011
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
K103291
BioHorizons Implant Systems, Inc.
Dental · 361d
Cleared Nov 03, 2011
BIOHORIZONS ABUTMENTS FOR ZIMMER
K103691
BioHorizons Implant Systems, Inc.
Dental · 321d
Cleared Oct 28, 2011
NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS
K112259
Nobel Biocare AB
Dental · 81d
Cleared Oct 03, 2011
PROSTHETIC SYSTEM
K110308
Osstem Implant Co., Ltd.
Dental · 243d
Cleared Aug 12, 2011
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
K110580
Straumann USA
Dental · 164d
Cleared Aug 11, 2011
ANODIZED HEALING COLLAR
K111852
Zimmer Dental, Inc.
Dental · 43d
Cleared Jun 30, 2011
GC AADVA BO AC ABUTMENTS
K103234
GC America, Inc.
Dental · 240d
Cleared Jun 23, 2011
15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE
K111581
Nobel Biocare AB
Dental · 16d
Cleared Dec 28, 2010
INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS
K100993
Prismatik Dentalcraft, Inc.
Dental · 263d