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