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
Oct 27, 2020
TIB Abutment System
Southern Implants (Pty), Ltd.
Dental
357d
Cleared
Sep 02, 2020
LOCATOR R-Tx
Ivory Super Holdco, Incp.
Dental
156d
Cleared
Aug 19, 2020
Straumann BLX Gold Abutments
Straumann USA, LLC (On Behalf of Institut Straumann Ag)
Dental
163d
Cleared
Aug 16, 2020
Sirona Dental CAD/CAM System with CEREC Chairside Software
Dentsply Sirona
Dental
251d
Cleared
Aug 13, 2020
Straumann® Retentive System – Novaloc TiN Abutments
Institut Straumann AG
Dental
286d
Cleared
Jul 22, 2020
Duranext Abutments
Elegant Dental Corp.
Dental
160d
Cleared
Jul 15, 2020
Magicore II System
Innobiosurg Co., Ltd.
Dental
30d
Cleared
Jul 06, 2020
MIS Ti-base Abutment
Dentsply Sirona
Dental
432d
Cleared
Jun 19, 2020
TruAbutment DS
Truabutment, Inc.
Dental
338d
Cleared
Jun 09, 2020
IBS Implant System II
Innobiosurg Co., Ltd.
Dental
78d
Cleared
May 18, 2020
UF(II) Bar holder abutment
Dio Corporation
Dental
164d
Cleared
May 08, 2020
Custom Legacy and Custom InterActive Titanium Abutments
Implant Direct Sybron Manufacturing, LLC
Dental
267d
Cleared
Apr 08, 2020
Panthera Dental Milled Bars
Panthera Dental, Inc.
Dental
247d
Cleared
Apr 06, 2020
Straumann Screw-Retained Abutments
Straumann USA, LLC
Dental
216d
Cleared
Mar 30, 2020
Universal Base Conical Connection (CC)
Nobel Biocare AG
Dental
82d
Cleared
Mar 25, 2020
MIS CONNECT Conical Connection System
Dentsply Sirona
Dental
141d
Cleared
Mar 24, 2020
Sherlock
Open Implants, LLC
Dental
113d
Cleared
Mar 09, 2020
Pre-Milled Blank
Arum Dentistry Co., Ltd.
Dental
90d
Cleared
Mar 05, 2020
ATLANTIS Abutment for MIS Conical Connection Implants
Dentsply Sirona
Dental
76d
Cleared
Mar 03, 2020
Atlantis suprastructures
Dentsply Sirona, Inc.
Dental
120d
Cleared
Feb 27, 2020
Rodo Abutment System
Rodo Medical, Inc.
Dental
93d
Cleared
Feb 26, 2020
Luna Dental Implant System- Healing Abutment
Shinhung Mst Co., Ltd.
Dental
30d
Cleared
Feb 21, 2020
UCLA CCM Abutment
Dio Corporation
Dental
184d
Cleared
Feb 13, 2020
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
Megagen Implant Co., Ltd.
Dental
143d