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
Jun 06, 2022
PrimeLOC Attachment System
Innovative Product Brands, Inc.
Dental
95d
Cleared
Jun 02, 2022
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
Institut Straumann AG
Dental
79d
Cleared
May 17, 2022
Neoss Individual Prosthetics
Neoss, Ltd.
Dental
377d
Cleared
Apr 14, 2022
High Retention Attachment System
Zest Anchors, LLC
Dental
73d
Cleared
Apr 08, 2022
TLX SRAs and TLX Gold Abutments
Institut Straumann AG
Dental
197d
Cleared
Apr 01, 2022
MIS Angulated multi-unit abutments
Dentsply Sirona
Dental
161d
Cleared
Mar 11, 2022
DESS Dental Smart Solutions
Terrats Medical SL
Dental
204d
Cleared
Mar 03, 2022
Osteon Precision Milled Suprastructure
Implant Solutions Pty Ltd (Osteon Medical)
Dental
191d
Cleared
Feb 04, 2022
Noris Medical Dental Implants System
Noris Medical , Ltd.
Dental
361d
Cleared
Feb 03, 2022
Healing Abutment, Cover Screw
Megagen Implant Co., Ltd.
Dental
321d
Cleared
Jan 25, 2022
INNO SLA Submerged Implant System
Cowellmedi Co., Ltd.
Dental
617d
Cleared
Jan 11, 2022
High Retention Attachment System
Zest Anchors, LLC
Dental
88d
Cleared
Dec 21, 2021
BellaTek Encode Emergence Healing Abutments
Biomet 3i, LLC
Dental
113d
Cleared
Dec 10, 2021
DESS Dental Smart Solutions
Terrats Medical SL
Dental
116d
Cleared
Nov 30, 2021
Sherlock
Open Implants, LLC
Dental
99d
Cleared
Nov 18, 2021
FAICO Dental Implant System and CAD/CAM Abutments
Faico Medical, LLC
Dental
154d
Cleared
Nov 15, 2021
DS Implants abutments provided with the EV connection
Dentsply Sirona
Dental
20d
Cleared
Oct 20, 2021
Multi-unit Abutment, Multi-unit Angled Abutment
Megagen Implant Co., Ltd.
Dental
296d
Cleared
Oct 09, 2021
Straumann CARES P-Series CAD/CAM System
Institut Straumann AG
Dental
290d
Cleared
Sep 24, 2021
Dynamic TiBase
Talladium Espa?a, SL
Dental
80d
Cleared
Sep 15, 2021
TruAbutment DS, TruBase
Truabutment, Inc.
Dental
275d
Cleared
Sep 10, 2021
s-Clean Pre-Milled Abutment Mini
Dentis Co., Ltd.
Dental
211d
Cleared
Aug 25, 2021
Premilled Titanium Block System
Innobiosurg Co., Ltd.
Dental
285d
Cleared
Aug 19, 2021
s-Clean Pre-Milled Abutment
Dentis Co., Ltd.
Dental
192d