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, Nobel Biocare AB and Terrats Medical SL.
716
Total
716
Cleared
169d
Avg days
1993
Since
716 devices
Cleared
Oct 10, 2019
Legacy SMARTBase Abutments
Implant Direct Sybron Manufacturing, LLC
Dental
132d
Cleared
Sep 30, 2019
UF(II) Anatomic abutment
Dio Corporation
Dental
263d
Cleared
Aug 26, 2019
IPS e.max CAD Abutment Solutions- extra systems
Ivoclar Vivadent, AG
Dental
95d
Cleared
Aug 12, 2019
Blue Sky Bio Zygomatic Implant System
Blue Sky Bio, LLC
Dental
165d
Cleared
Aug 05, 2019
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
Prismatik Dentalcraft, Inc.
Dental
90d
Cleared
Jul 15, 2019
A.B. DENTAL DEVICES Dental Implants System
A.B. Dental Device , Ltd.
Dental
311d
Cleared
Jul 12, 2019
Osstem Abutment System
Osstem Implant Co., Ltd.
Dental
343d
Cleared
Jul 10, 2019
Conometric Abutments
Dentsply Sirona, Inc.
Dental
247d
Cleared
Jul 02, 2019
Certain BellaTek Express and BellaTek Flex Abutments
Biomet 3i
Dental
231d
Cleared
Jun 28, 2019
Straumann CI RD Ceramic Healing Caps
Institut Straumann AG
Dental
106d
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