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
Feb 10, 2020
Elos Accurate Hybrid Base
Elos Medtech Pinol A/S
Dental
207d
Cleared
Feb 06, 2020
Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Dental
206d
Cleared
Jan 29, 2020
TruAbutment DS
Truabutment, Inc.
Dental
447d
Cleared
Jan 23, 2020
Healing Abutments and Cover Screws
Dentium Co., Ltd.
Dental
139d
Cleared
Jan 06, 2020
Multi-unit Abutments
Medentika GmbH
Dental
252d
Cleared
Jan 03, 2020
Straumann Ceramic Healing Abutments
Institut Straumann AG
Dental
84d
Cleared
Jan 02, 2020
Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Dental
115d
Cleared
Dec 19, 2019
Neodent Implant System- GM Titanium Base for Bridge
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
125d
Cleared
Dec 09, 2019
TSV BellaTek Express and BellaTek Flex Abutments
Biomet 3i, LLC
Dental
87d
Cleared
Dec 05, 2019
Neodent Implant System - Temporary Abutments
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
216d
Cleared
Dec 05, 2019
Southern Implants PEEK Abutments
Southern Implants (Pty), Ltd.
Dental
210d
Cleared
Nov 10, 2019
DESS Dental Smart Solutions
Terrats Medical SL
Dental
108d
Cleared
Nov 04, 2019
Scan Abutments and Comfort Caps
Dentium Co., Ltd.
Dental
138d
Cleared
Oct 28, 2019
Straumann PUREloc abutments
Institut Straumann AG
Dental
90d
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