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
121–144 of 713
Cleared Sep 14, 2023
LW Retraction Cap
K231079
Ossvis Co., Ltd.
Dental · 150d
Cleared Sep 01, 2023
Elos Accurate Hybrid Base
K230317
Elos Medtech Pinol A/S
Dental · 207d
Cleared Aug 24, 2023
ZENEX FreeMilling & CCM Cast Abutment
K231557
Izenimplant Co., Ltd.
Dental · 86d
Cleared Aug 18, 2023
Eco Abutment, Multiunit Abutment
K220253
Dio Corporation
Dental · 564d
Cleared Aug 15, 2023
Implant-One System
K231455
Implant Logistics, Inc.
Dental · 89d
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
Bonafix TiBase
K221673
Zentek Medical, LLC
Dental · 400d
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
SIMDA Abutment
K223663
Simda Co., Ltd.
Dental · 168d
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 12, 2023
IU Implant System Abutment
K221969
Warantec Co., Ltd.
Dental · 311d
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 25, 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
K230218
Dental Direkt GmbH
Dental · 89d
Cleared Apr 24, 2023
Klockner Abutments
K230103
SOADCO, S.L.
Dental · 101d
Cleared Apr 17, 2023
TIB Abutments
K222469
Southern Implants (Pty), Ltd.
Dental · 244d