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
433–456 of 713
Cleared Feb 25, 2014
NEODENT IMPLANT SYSTEM
K133696
Jjgc Industria E Comercio DE Materiais Dentarios S
Dental · 84d
Cleared Feb 21, 2014
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
K132219
Straumann USA, LLC
Dental · 219d
Cleared Jan 30, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
K132746
Nobel Biocare USA, LLC
Dental · 149d
Cleared Jan 22, 2014
ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
K131644
Dentsply International, Inc.
Dental · 231d
Cleared Jan 15, 2014
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
K132844
Straumann USA, LLC
Dental · 126d
Cleared Jan 10, 2014
ET PROSTHETIC SYSTEM
K130662
Osstem Implant Co., Ltd.
Dental · 304d
Cleared Dec 20, 2013
MULTI ANGLED ABUTMENT SYSTEM
K132067
Hiossen, Inc.
Dental · 170d
Cleared Oct 31, 2013
IPS E.MAX CAD ABUTMENT SOLUTIONS
K132209
Ivoclar Vivadent, AG
Dental · 107d
Cleared Oct 24, 2013
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
K122295
Core 3D Protech, S.L.
Dental · 450d
Cleared Sep 23, 2013
SFI-BAR
K131526
Cendres & Metaux SA
Dental · 118d
Cleared Sep 17, 2013
CREODENT SOLIDEX CUSTOM ABUTMENT
K113738
Creodent Prosthetics, Ltd.
Dental · 637d
Cleared Aug 26, 2013
ITERO SOFTWARE
K131101
Cadent, Ltd. an Align Technology Company
Dental · 129d
Cleared Jul 19, 2013
KLOCKNER DENTAL IMPLANT ABUTMENTS
K122988
SOADCO, S.L.
Dental · 296d
Cleared Jul 07, 2013
SFI BAR ABUTMENTS
K130183
Sterngold Dental, LLC
Dental · 163d
Cleared Jul 05, 2013
ISUS IMPLANT SUPRASTRUCTURES
K122424
Dentsply International, Inc.
Dental · 330d
Cleared Jul 01, 2013
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
K130408
Sterngold Dental, LLC
Dental · 132d
Cleared Jun 28, 2013
ET SMARTFIT ABUTMENT
K123627
Hiossen, Inc.
Dental · 217d
Cleared Jun 28, 2013
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
K130808
Straumann USA
Dental · 95d
Cleared Jun 21, 2013
CERTAIN BELLATEK PROVISIONAL ABUTMENTS
K130310
Biomet 3i
Dental · 134d
Cleared Jun 05, 2013
NOBELPROCERA PEEK ABUTMENTS
K120954
Nobel Biocare AB
Dental · 432d
Cleared May 30, 2013
BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT
K123491
Biodenta Swiss AG
Dental · 198d
Cleared May 03, 2013
BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
K122559
Biodenta Swiss AG
Dental · 254d
Cleared May 01, 2013
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
K130216
Dentsply Implant
Dental · 92d
Cleared Apr 26, 2013
MULTI ANGLED ABUTMENT
K123755
Osstem Implant Co., Ltd.
Dental · 140d