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
Nov 16, 2015
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
Prismatik Dentalcraft, Inc.
Dental
137d
Cleared
Nov 05, 2015
NaturalLine Abutment
Ot Medical GmbH
Dental
161d
Cleared
Oct 23, 2015
Medentika CAD/CAM Abutments
Medentika GmbH
Dental
267d
Cleared
Oct 08, 2015
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
Neoss, Ltd.
Dental
206d
Cleared
Oct 08, 2015
OsteoReady ZircoSeal Abutments
Osteoready, LLC
Dental
160d
Cleared
Oct 07, 2015
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
Prismatik Dentalcraft, Inc.
Dental
138d
Cleared
Oct 01, 2015
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
Prismatik Dentalcraft, Inc.
Dental
294d
Cleared
Sep 21, 2015
Telio CAD Abutment Solutions
Ivoclar Vivadent, AG
Dental
103d
Cleared
Sep 16, 2015
ArgenIS Titanium Abutments
The Argen Corporation
Dental
328d
Cleared
Sep 16, 2015
Straumann CARES Titanium Alloy (TAN) Abutment
Straumann USA, LLC
Dental
166d
Cleared
Sep 11, 2015
Straumann Variobase for CEREC
Straumann USA, LLC
Dental
116d
Cleared
Aug 10, 2015
Straumann Screw-Retained Abutment
Straumann USA, LLC
Dental
136d
Cleared
Aug 10, 2015
NC Straumann Screw Retained Abutments
Straumann USA, LLC
Dental
91d
Cleared
Aug 05, 2015
NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges
Straumann USA, LLC
Dental
96d
Cleared
Jul 31, 2015
DIGITEK TITANIUM ABUTMENT
Digitek Dental Solutions Limited
Dental
375d
Cleared
Jul 24, 2015
LOCATOR RTx
Zest Anchors, Inc.
Dental
168d
Cleared
Jul 13, 2015
Neodent Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S
Dental
151d
Cleared
Jul 02, 2015
Biodenta Customized Abutment-Hybrid
Biodenta Swiss AG
Dental
146d
Cleared
Jun 25, 2015
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
Zimmer Dental, Inc.
Dental
197d
Cleared
Jun 11, 2015
SternSnap Angled Attachment
Sterngold Dental, LLC
Dental
128d
Cleared
Jun 04, 2015
CreoDent Solidex Customized Abutment
Creodent Prosthetics, Ltd.
Dental
150d
Cleared
May 01, 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
Zimmer Dental, Inc.
Dental
140d
Cleared
Feb 20, 2015
MEDENTIKA ABUTMENT SYSTEM
Medentika GmbH
Dental
198d
Cleared
Feb 17, 2015
CONELOG Titanium base CAD/CAM
Altatec GmbH
Dental
89d