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 Terrats Medical SL, Institut Straumann AG and Dentis Co., Ltd..

702
Total
702
Cleared
169d
Avg days
1993
Since
702 devices
97–120 of 702
Cleared Dec 05, 2023
SS Abutment System
K232220
Osstem Implant Co., Ltd.
Dental · 132d
Cleared Nov 21, 2023
Meta G UCLA Abutment
K232546
Cowellmedi Co., Ltd.
Dental · 90d
Cleared Nov 14, 2023
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
K231097
Prismatik Dentalcraft, Inc.
Dental · 210d
Cleared Oct 30, 2023
AOT & T-L Abutment
K231874
Truabutment, Inc.
Dental · 126d
Cleared Sep 26, 2023
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
K223496
Prismatik Dentalcraft, Inc.
Dental · 309d
Cleared Sep 15, 2023
BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
K231827
B.T.I. Biotechnology Institute, Sl.
Dental · 86d
Cleared Sep 01, 2023
Elos Accurate Hybrid Base
K230317
Elos Medtech Pinol A/S
Dental · 207d
Cleared Aug 18, 2023
Eco Abutment, Multiunit Abutment
K220253
Dio Corporation
Dental · 564d
Cleared Aug 14, 2023
DESS Dental Smart Solutions
K231434
Terrats Medical SL
Dental · 89d
Cleared Aug 04, 2023
Dentis s-Clean Regular Abutment
K230126
Dentis Co., Ltd.
Dental · 199d
Cleared Aug 01, 2023
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
K230873
Southern Implants (Pty), Ltd.
Dental · 124d
Cleared Jul 14, 2023
Neodent Implant System - Zirconia Implant System
K222026
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 368d
Cleared Jul 11, 2023
Dentis i-Clean System
K230307
Dentis Co., Ltd.
Dental · 158d
Cleared Jun 20, 2023
SMARTbase Abutment System
K223535
Implant Direct Sybron Manufacturing, LLC
Dental · 209d
Cleared May 25, 2023
Dentis s-Clean SQ-SL Narrow Implant System
K230246
Dentis Co., Ltd.
Dental · 115d
Cleared May 24, 2023
s-Clean Link Abutment Narrow
K230523
Dentis Co., Ltd.
Dental · 86d
Cleared May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
K222836
Institut Straumann AG
Dental · 237d
Cleared May 03, 2023
Dentis I-FIX Abutment
K230203
Dentis Co., Ltd.
Dental · 98d
Cleared Apr 28, 2023
ET Abutment System
K222636
Hiossen, Inc.
Dental · 240d
Cleared Apr 28, 2023
Customized Abutment
K223634
Arum Dentistry Co., Ltd.
Dental · 144d
Cleared Apr 28, 2023
Titanium Abutment Blank Nobel Biocare N1 TCC
K223677
Nobel Biocare AB
Dental · 141d
Cleared Apr 17, 2023
TIB Abutments
K222469
Southern Implants (Pty), Ltd.
Dental · 244d
Cleared Apr 13, 2023
DESS Dental Smart Solutions
K230143
Terrats Medical SL
Dental · 85d
Cleared Apr 06, 2023
S.I.N. Dental Implant System
K230069
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 86d