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 26, 2019
Straumann CARES Screw-Retained Bridges and Bars
Institut Straumann AG
Dental
155d
Cleared
Jun 26, 2019
Elos Accurate® Customized Abutment
Elos Medtech Pinol A/S
Dental
135d
Cleared
Jun 20, 2019
Panthera Dental Milled Bars
Panthera Dental, Inc.
Dental
181d
Cleared
May 17, 2019
SD Abutment
Surgident Co., Ltd.
Dental
543d
Cleared
Apr 17, 2019
Straumann BLX Variobase Abutment
Institut Straumann AG
Dental
90d
Cleared
Apr 16, 2019
MIST IC
Imagine Milling Technologies, LLC
Dental
239d
Cleared
Apr 08, 2019
Straumann BLX Line Extension - New Abutments
Institut Straumann AG
Dental
90d
Cleared
Mar 18, 2019
Preat Abutments
Preat Corporation
Dental
90d
Cleared
Jan 29, 2019
Cortex CAD/CAM Abutments
Cortex Dental Implants Industries , Ltd.
Dental
228d
Cleared
Jan 28, 2019
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
Mis Implants Technologies , Ltd.
Dental
165d
Cleared
Jan 07, 2019
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
Medentika GmbH
Dental
308d
Cleared
Dec 21, 2018
DIO CAD/CAM Abutment
Dio Corporation
Dental
246d
Cleared
Dec 12, 2018
On1 Universal Abutment
Nobel Biocare AB
Dental
153d
Cleared
Nov 23, 2018
A.B. Dental Devices Dental Implants System
A.B. Dental Device , Ltd.
Dental
183d
Cleared
Nov 16, 2018
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
Dentalpoint AG
Dental
297d
Cleared
Oct 31, 2018
Universal Base Abutment
Nobel Biocare AB
Dental
208d
Cleared
Oct 11, 2018
Sirona Dental CAD/CAM System
Dentsply Sirona
Dental
122d
Cleared
Oct 05, 2018
Straumann SC Variobase Abutments
Institut Straumann AG
Dental
283d
Cleared
Sep 28, 2018
BioHorizons CAD/CAM Bars
BioHorizons Implant Systems, Inc.
Dental
165d
Cleared
Sep 11, 2018
TruBase S
Truabutment, Inc.
Dental
474d
Cleared
Aug 15, 2018
InterActive SMARTBase Abutments
Implant Direct Sybron Manufacturing, LLC
Dental
85d
Cleared
Jul 18, 2018
ATLANTIS Conus Structure
Dentsply Sirona
Dental
76d
Cleared
Jul 17, 2018
Straumann Variobase for Bridge/Bar Cylindrical
Institut Straumann AG
Dental
200d
Cleared
Jun 15, 2018
DESS Dental Smart Solutions
Terrats Medical SL
Dental
175d