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
385–408 of 713
Cleared Nov 16, 2015
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798
Prismatik Dentalcraft, Inc.
Dental · 137d
Cleared Nov 05, 2015
NaturalLine Abutment
K151432
Ot Medical GmbH
Dental · 161d
Cleared Oct 23, 2015
Medentika CAD/CAM Abutments
K150203
Medentika GmbH
Dental · 267d
Cleared Oct 08, 2015
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
K150669
Neoss, Ltd.
Dental · 206d
Cleared Oct 08, 2015
OsteoReady ZircoSeal Abutments
K151169
Osteoready, LLC
Dental · 160d
Cleared Oct 07, 2015
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
K151375
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
K143515
Prismatik Dentalcraft, Inc.
Dental · 294d
Cleared Sep 21, 2015
Telio CAD Abutment Solutions
K151564
Ivoclar Vivadent, AG
Dental · 103d
Cleared Sep 16, 2015
ArgenIS Titanium Abutments
K143051
The Argen Corporation
Dental · 328d
Cleared Sep 16, 2015
Straumann CARES Titanium Alloy (TAN) Abutment
K150899
Straumann USA, LLC
Dental · 166d
Cleared Sep 11, 2015
Straumann Variobase for CEREC
K151324
Straumann USA, LLC
Dental · 116d
Cleared Aug 10, 2015
Straumann Screw-Retained Abutment
K150814
Straumann USA, LLC
Dental · 136d
Cleared Aug 10, 2015
NC Straumann Screw Retained Abutments
K151247
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
K151157
Straumann USA, LLC
Dental · 96d
Cleared Jul 31, 2015
DIGITEK TITANIUM ABUTMENT
K141970
Digitek Dental Solutions Limited
Dental · 375d
Cleared Jul 24, 2015
LOCATOR RTx
K150295
Zest Anchors, Inc.
Dental · 168d
Cleared Jul 13, 2015
Neodent Implant System
K150367
Jjgc Industria E Comercio DE Materiais Dentarios S
Dental · 151d
Cleared Jul 02, 2015
Biodenta Customized Abutment-Hybrid
K150296
Biodenta Swiss AG
Dental · 146d
Cleared Jun 25, 2015
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
K143505
Zimmer Dental, Inc.
Dental · 197d
Cleared Jun 11, 2015
SternSnap Angled Attachment
K150250
Sterngold Dental, LLC
Dental · 128d
Cleared Jun 04, 2015
CreoDent Solidex Customized Abutment
K150012
Creodent Prosthetics, Ltd.
Dental · 150d
Cleared May 01, 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528
Zimmer Dental, Inc.
Dental · 140d
Cleared Feb 20, 2015
MEDENTIKA ABUTMENT SYSTEM
K142167
Medentika GmbH
Dental · 198d
Cleared Feb 17, 2015
CONELOG Titanium base CAD/CAM
K143337
Altatec GmbH
Dental · 89d