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
Cleared
Feb 25, 2014
NEODENT IMPLANT SYSTEM
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,
Straumann USA, LLC
Dental
219d
Cleared
Jan 30, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
Nobel Biocare USA, LLC
Dental
149d
Cleared
Jan 22, 2014
ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
Dentsply International, Inc.
Dental
231d
Cleared
Jan 15, 2014
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
Straumann USA, LLC
Dental
126d
Cleared
Jan 10, 2014
ET PROSTHETIC SYSTEM
Osstem Implant Co., Ltd.
Dental
304d
Cleared
Dec 20, 2013
MULTI ANGLED ABUTMENT SYSTEM
Hiossen, Inc.
Dental
170d
Cleared
Oct 31, 2013
IPS E.MAX CAD ABUTMENT SOLUTIONS
Ivoclar Vivadent, AG
Dental
107d
Cleared
Oct 24, 2013
CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
Core 3D Protech, S.L.
Dental
450d
Cleared
Sep 23, 2013
SFI-BAR
Cendres & Metaux SA
Dental
118d
Cleared
Sep 17, 2013
CREODENT SOLIDEX CUSTOM ABUTMENT
Creodent Prosthetics, Ltd.
Dental
637d
Cleared
Aug 26, 2013
ITERO SOFTWARE
Cadent, Ltd. an Align Technology Company
Dental
129d
Cleared
Jul 19, 2013
KLOCKNER DENTAL IMPLANT ABUTMENTS
SOADCO, S.L.
Dental
296d
Cleared
Jul 07, 2013
SFI BAR ABUTMENTS
Sterngold Dental, LLC
Dental
163d
Cleared
Jul 05, 2013
ISUS IMPLANT SUPRASTRUCTURES
Dentsply International, Inc.
Dental
330d
Cleared
Jul 01, 2013
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
Sterngold Dental, LLC
Dental
132d
Cleared
Jun 28, 2013
ET SMARTFIT ABUTMENT
Hiossen, Inc.
Dental
217d
Cleared
Jun 28, 2013
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
Straumann USA
Dental
95d
Cleared
Jun 21, 2013
CERTAIN BELLATEK PROVISIONAL ABUTMENTS
Biomet 3i
Dental
134d
Cleared
Jun 05, 2013
NOBELPROCERA PEEK ABUTMENTS
Nobel Biocare AB
Dental
432d
Cleared
May 30, 2013
BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT
Biodenta Swiss AG
Dental
198d
Cleared
May 03, 2013
BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
Biodenta Swiss AG
Dental
254d
Cleared
May 01, 2013
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
Dentsply Implant
Dental
92d
Cleared
Apr 26, 2013
MULTI ANGLED ABUTMENT
Osstem Implant Co., Ltd.
Dental
140d