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..

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
193–216 of 713
Cleared Oct 20, 2021
Multi-unit Abutment, Multi-unit Angled Abutment
K203808
Megagen Implant Co., Ltd.
Dental · 296d
Cleared Oct 09, 2021
Straumann CARES P-Series CAD/CAM System
K203750
Institut Straumann AG
Dental · 290d
Cleared Sep 24, 2021
Dynamic TiBase
K212108
Talladium Espa?a, SL
Dental · 80d
Cleared Sep 15, 2021
TruAbutment DS, TruBase
K203649
Truabutment, Inc.
Dental · 275d
Cleared Sep 10, 2021
s-Clean Pre-Milled Abutment Mini
K210410
Dentis Co., Ltd.
Dental · 211d
Cleared Aug 25, 2021
Premilled Titanium Block System
K203344
Innobiosurg Co., Ltd.
Dental · 285d
Cleared Aug 19, 2021
s-Clean Pre-Milled Abutment
K210362
Dentis Co., Ltd.
Dental · 192d
Cleared Aug 06, 2021
Kisses Plus Implant System
K200193
Achimhai Medical Corporation
Dental · 557d
Cleared Aug 04, 2021
DESS Dental Smart Solutions
K203464
Terrats Medical SL
Dental · 253d
Cleared Aug 02, 2021
Neodent Implant System - Mini Abutment 60°
K203542
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 242d
Cleared Jul 28, 2021
MIS Ti-base abutment
K211225
Dentsply Sirona
Dental · 96d
Cleared Jul 23, 2021
IS Multi Unit Abutment System
K210903
Neobiotech Co., Ltd.
Dental · 119d
Cleared Jul 08, 2021
TruAbutment DS, TruBase
K202579
Truabutment, Inc.
Dental · 303d
Cleared Jun 23, 2021
Straumann CARES M-Series CAD/CAM System
K203456
Institut Straumann AG
Dental · 212d
Cleared Jun 04, 2021
TruBase S
K201842
Truabutment, Inc.
Dental · 333d
Cleared Apr 27, 2021
AccelX Abutments
K203240
Integrated Dental Systems, LLC
Dental · 175d
Cleared Apr 02, 2021
CreoDent Solidex Customized Abutment
K202909
Creodent Prosthetics, Ltd.
Dental · 185d
Cleared Mar 26, 2021
TruAbutment DS, TruBase S
K201197
Truabutment, Inc.
Dental · 326d
Cleared Mar 18, 2021
Straumann Immediate Temporary Abutments
K201681
Institut Straumann AG
Dental · 269d
Cleared Mar 16, 2021
Multi-unit Abutments for CONELOG
K203252
BioHorizons Implant Systems, Inc.
Dental · 132d
Cleared Feb 19, 2021
Elos Accurate Hybrid Base
K201860
Elos Medtech Pinol A/S
Dental · 228d
Cleared Feb 12, 2021
Straumann Variobase C
K192742
Institut Straumann AG
Dental · 501d
Cleared Feb 12, 2021
Straumann TLX Novaloc and Cementable Abutments
K203355
Institut Straumann AG
Dental · 88d
Cleared Jan 29, 2021
Neodent Implant System - Zirconia Implant System
K202282
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 170d