NHA · Class II · 21 CFR 872.3630

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
241–264 of 713
Cleared Mar 09, 2020
Pre-Milled Blank
K193425
Arum Dentistry Co., Ltd.
Dental · 90d
Cleared Mar 05, 2020
ATLANTIS Abutment for MIS Conical Connection Implants
K193529
Dentsply Sirona
Dental · 76d
Cleared Mar 03, 2020
Atlantis suprastructures
K193064
Dentsply Sirona, Inc.
Dental · 120d
Cleared Feb 27, 2020
Rodo Abutment System
K193274
Rodo Medical, Inc.
Dental · 93d
Cleared Feb 26, 2020
Luna Dental Implant System- Healing Abutment
K200189
Shinhung Mst Co., Ltd.
Dental · 30d
Cleared Feb 21, 2020
UCLA CCM Abutment
K192263
Dio Corporation
Dental · 184d
Cleared Feb 13, 2020
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
K192614
Megagen Implant Co., Ltd.
Dental · 143d
Cleared Feb 10, 2020
Elos Accurate Hybrid Base
K191919
Elos Medtech Pinol A/S
Dental · 207d
Cleared Feb 06, 2020
Elos Accurate Customized Abutment
K191890
Elos Medtech Pinol A/S
Dental · 206d
Cleared Jan 29, 2020
TruAbutment DS
K183106
Truabutment, Inc.
Dental · 447d
Cleared Jan 23, 2020
Healing Abutments and Cover Screws
K192436
Dentium Co., Ltd.
Dental · 139d
Cleared Jan 06, 2020
Multi-unit Abutments
K191123
Medentika GmbH
Dental · 252d
Cleared Jan 03, 2020
Straumann Ceramic Healing Abutments
K192893
Institut Straumann AG
Dental · 84d
Cleared Jan 02, 2020
Elos Accurate Customized Abutment
K192457
Elos Medtech Pinol A/S
Dental · 115d
Cleared Dec 19, 2019
Neodent Implant System- GM Titanium Base for Bridge
K192229
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 125d
Cleared Dec 09, 2019
TSV BellaTek Express and BellaTek Flex Abutments
K192522
Biomet 3i, LLC
Dental · 87d
Cleared Dec 05, 2019
Neodent Implant System - Temporary Abutments
K191191
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 216d
Cleared Dec 05, 2019
Southern Implants PEEK Abutments
K191250
Southern Implants (Pty), Ltd.
Dental · 210d
Cleared Nov 10, 2019
DESS Dental Smart Solutions
K191986
Terrats Medical SL
Dental · 108d
Cleared Nov 04, 2019
Scan Abutments and Comfort Caps
K191634
Dentium Co., Ltd.
Dental · 138d
Cleared Oct 28, 2019
Straumann PUREloc abutments
K192029
Institut Straumann AG
Dental · 90d
Cleared Oct 10, 2019
Legacy SMARTBase Abutments
K191458
Implant Direct Sybron Manufacturing, LLC
Dental · 132d
Cleared Sep 30, 2019
UF(II) Anatomic abutment
K190048
Dio Corporation
Dental · 263d
Cleared Aug 26, 2019
IPS e.max CAD Abutment Solutions- extra systems
K191382
Ivoclar Vivadent, AG
Dental · 95d