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, Terrats Medical SL and Dentsply Sirona.

706
Total
706
Cleared
169d
Avg days
1993
Since
706 devices
193–216 of 706
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
Cleared Dec 18, 2020
Blue Sky Bio CAD-CAM Abutments
K202026
Blue Sky Bio, LLC
Dental · 149d
Cleared Dec 16, 2020
CreoDent Solidex Customized Abutment and Screw
K202095
Creodent Prosthetics, Ltd.
Dental · 140d
Cleared Dec 08, 2020
CARES Screw - Retained Bars and Bridges (SRBB)
K201711
Medentika GmbH
Dental · 168d
Cleared Dec 03, 2020
Magic UCLA Abutment System
K202418
Innobiosurg Co., Ltd.
Dental · 101d
Cleared Dec 03, 2020
NobelProcera Zirconia Implant Bridge
K202452
Nobel Biocare AB
Dental · 98d
Cleared Nov 25, 2020
PRE-MILLED Abutment
K202269
Mit Global Co., Ltd.
Dental · 106d
Cleared Nov 16, 2020
Telio CAD Abutment Solutions- extra systems
K193193
Ivoclar Vivadent, AG
Dental · 363d