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
145–168 of 706
Cleared Jan 13, 2023
s-Clean Link Abutment
K222913
Dentis Co., Ltd.
Dental · 109d
Cleared Jan 12, 2023
MU System
K222976
Dentis Co., Ltd.
Dental · 106d
Cleared Jan 11, 2023
DD Solid Connect® CAD/CAM Abutments
K191111
Dental Direkt GmbH
Dental · 1356d
Cleared Dec 29, 2022
BioClean Implant Restorative System
K222984
Bioclean Dental, LLC
Dental · 92d
Cleared Dec 02, 2022
CreoDent Solidex Customized Abutment and Screw
K220390
Creodent Prosthetics, Ltd.
Dental · 294d
Cleared Dec 01, 2022
MIST IC
K222368
Imagine Milling Technologies, LLC
Dental · 118d
Cleared Nov 30, 2022
Elos Accurate Customized Abutment
K222044
Elos Medtech Pinol A/S
Dental · 142d
Cleared Nov 10, 2022
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
K220562
Megagen Implant Co., Ltd.
Dental · 255d
Cleared Oct 27, 2022
DESS Dental Smart Solutions
K222288
Terrats Medical SL
Dental · 90d
Cleared Oct 26, 2022
Preat Abutments
K220823
Preat Corporation
Dental · 219d
Cleared Oct 26, 2022
DESS Dental Smart Solutions
K222269
Terrats Medical SL
Dental · 90d
Cleared Oct 21, 2022
IPD Dental Implant Abutments
K222215
Implant Protesis Dental 2004, S.L.
Dental · 88d
Cleared Oct 20, 2022
BTI Interna Dental Implant System UnicCa - Prosthetic Components
K213106
B.T.I. Biotechnology Institute, Sl.
Dental · 391d
Cleared Sep 23, 2022
A.B. Dental Devices Dental Implants System
K202144
A.B. Dental Device , Ltd.
Dental · 784d
Cleared Sep 16, 2022
Esthetic Abutments Nobel Biocare N1
K220339
Nobel Biocare Services AG
Dental · 221d
Cleared Sep 15, 2022
Dynamic TiBase
K221966
Talladium Espana, SL
Dental · 72d
Cleared Sep 08, 2022
Osstem Abutment System
K221684
Osstem Implant Co., Ltd.
Dental · 90d
Cleared Aug 10, 2022
KDG Abutments
K221381
Keystone Dental, Inc.
Dental · 89d
Cleared Jul 29, 2022
NobelProcera Zirconia N1 Base
K220048
Nobel Biocare Services AG
Dental · 204d
Cleared Jul 14, 2022
TruAbutment DS, TruBase
K213961
Truabutment, Inc.
Dental · 206d
Cleared Jul 05, 2022
Osteon Precision Milled Suprastructure
K221019
Implant Solutions Pty Ltd (Aka Osteon Medical)
Dental · 90d
Cleared Jun 21, 2022
Sherlock
K220482
Open Implants, LLC
Dental · 123d
Cleared Jun 16, 2022
Dentis s-Clean Abutment Mini
K220440
Dentis Co., Ltd.
Dental · 120d
Cleared Jun 16, 2022
Straumann TLX Variobase C
K220878
Institut Straumann AG
Dental · 83d