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
97–120 of 706
Cleared Dec 21, 2023
Elos Accurate Customized Abutment
K231307
Elos Medtech Pinol A/S
Dental · 230d
Cleared Dec 20, 2023
INNO SLA Submerged Hybrid Ti-Base System
K231411
Cowellmedi Co., Ltd.
Dental · 218d
Cleared Dec 19, 2023
Angled Abutment
K232560
Arum Dentistry Co., Ltd.
Dental · 118d
Cleared Dec 13, 2023
Neodent Implant System - Zirconia Implant System
K231803
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental · 176d
Cleared Dec 08, 2023
BTI Interna Prosthetic Components
K232750
B.T.I. Biotechnology Institute, Sl.
Dental · 91d
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 17, 2023
Multi-Unit DAS System
K231559
Talladium Espa?a, SL
Dental · 171d
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 Oct 26, 2023
SIMDA abutment
K232271
Simda Co., Ltd.
Dental · 87d
Cleared Oct 17, 2023
Dynamic TiBase
K232151
Talladium Espa?a, SL
Dental · 90d
Cleared Oct 10, 2023
IPD Dental Implant Abutments
K231413
Implant Protesis Dental 2004, S.L.
Dental · 147d
Cleared Oct 02, 2023
Warantec Custom Abutment
K221972
Warantec Co., Ltd.
Dental · 454d
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
LW UCLA Abutment
K231235
Ossvis Co., Ltd.
Dental · 140d
Cleared Sep 15, 2023
BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
K231827
B.T.I. Biotechnology Institute, Sl.
Dental · 86d
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