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
313–336 of 712
Cleared Oct 26, 2017
Healing Cap Multi-Unit Titanium
K171142
Nobel Biocare AB
Dental · 191d
Cleared Sep 22, 2017
Straumann CARES Golden Ti/TiN Abutments
K162848
Institut Straumann AG
Dental · 346d
Cleared Aug 14, 2017
ATLANTIS suprastructures
K163398
Dentsply Sirona
Dental · 252d
Cleared Jun 07, 2017
Straumann Variobase Abutments
K170354
Institut Straumann AG
Dental · 121d
Cleared Jun 07, 2017
Straumann Variobase Abutments
K170356
Institut Straumann AG
Dental · 121d
Cleared Jun 06, 2017
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
K170044
Prismatik Dentalcraft, Inc.
Dental · 152d
Cleared May 22, 2017
OSSTEM Implant System - Abutment
K161689
Osstem Implant Co., Ltd.
Dental · 336d
Cleared Apr 25, 2017
ET US SS Prosthetic system
K160670
Osstem Implant Co., Ltd.
Dental · 411d
Cleared Mar 31, 2017
Multibase Abutments EV and ATLANTIS Suprastructures
K163350
Dentsply Sirona
Dental · 121d
Cleared Mar 16, 2017
Multi-unit Abutment Plus
K161416
Nobel Biocare AB
Dental · 297d
Cleared Feb 28, 2017
On1 Concept
K161655
Nobel Biocare AB
Dental · 257d
Cleared Dec 05, 2016
Transfer & Angled Abutment
K153015
Osstem Implant Co., Ltd.
Dental · 417d
Cleared Nov 22, 2016
Temporary Snap Abutment
K161435
Nobel Biocare AB
Dental · 182d
Cleared Nov 04, 2016
Inclusive Abutments
K160979
Prismatik Dentalcraft, Inc.
Dental · 211d
Cleared Oct 28, 2016
Link Abutment for CEREC
K160519
Osstem Implant Co., Ltd.
Dental · 246d
Cleared Oct 07, 2016
Straumann Sterile Healing Solution
K161677
Institut Straumann AG
Dental · 112d
Cleared Sep 21, 2016
ATLANTIS ISUS Implant Suprastructures
K160207
Dentsply International, Inc.
Dental · 237d
Cleared Aug 29, 2016
ATLANTIS Abutment for HIOSSEN ET implant
K160626
Dentsply Sirona
Dental · 175d
Cleared Aug 26, 2016
ATLANTIS Abutment for CONELOG implant
K161030
Dentsply Sirona
Dental · 135d
Cleared Jul 25, 2016
NobelProcera HT ML FCZ Implant Bridge and Framework
K160158
Nobel Biocare AB
Dental · 180d
Cleared Jun 02, 2016
NobelDesign Software
K153036
Nobel Biocare AB
Dental · 227d
Cleared Feb 19, 2016
ATLANTIS ISUS
K151439
Dentsply International, Inc.
Dental · 266d
Cleared Jan 14, 2016
ATLANTIS Abutment for NobelActive 3.0
K151039
Dentsply International, Inc.
Dental · 269d
Cleared Jan 13, 2016
BioHorizons CAD/CAM Abutments
K151621
BioHorizons Implant Systems, Inc.
Dental · 211d