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.
713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
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
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