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, Terrats Medical SL and Dentsply Sirona.

706
Total
706
Cleared
169d
Avg days
1993
Since
706 devices
241–264 of 706
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
Cleared Aug 12, 2019
Blue Sky Bio Zygomatic Implant System
K190491
Blue Sky Bio, LLC
Dental · 165d
Cleared Aug 05, 2019
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
K191222
Prismatik Dentalcraft, Inc.
Dental · 90d
Cleared Jul 15, 2019
A.B. DENTAL DEVICES Dental Implants System
K182455
A.B. Dental Device , Ltd.
Dental · 311d
Cleared Jul 12, 2019
Osstem Abutment System
K182091
Osstem Implant Co., Ltd.
Dental · 343d
Cleared Jul 10, 2019
Conometric Abutments
K183079
Dentsply Sirona, Inc.
Dental · 247d
Cleared Jul 02, 2019
Certain BellaTek Express and BellaTek Flex Abutments
K183138
Biomet 3i
Dental · 231d
Cleared Jun 28, 2019
Straumann CI RD Ceramic Healing Caps
K190654
Institut Straumann AG
Dental · 106d