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
337–360 of 713
Cleared May 22, 2017
OSSTEM Implant System - Abutment
K161689
Osstem Implant Co., Ltd.
Dental · 336d
Cleared May 08, 2017
CreoDent Solidex Customized Abutment
K162734
Creodent Prosthetics, Ltd.
Dental · 220d
Cleared Apr 25, 2017
ET US SS Prosthetic system
K160670
Osstem Implant Co., Ltd.
Dental · 411d
Cleared Mar 31, 2017
Multibase Abutments EV and ATLANTIS Suprastructures
K163350
Dentsply Sirona
Dental · 121d
Cleared Mar 24, 2017
PREMIUM - SHELTA Prosthetic Components
K162028
Sweden & Martina S.P.A.
Dental · 245d
Cleared Mar 16, 2017
Multi-unit Abutment Plus
K161416
Nobel Biocare AB
Dental · 297d
Cleared Feb 28, 2017
On1 Concept
K161655
Nobel Biocare AB
Dental · 257d
Cleared Jan 30, 2017
ET Hybrid Abutment
K162390
Hiossen, Inc.
Dental · 157d
Cleared Dec 16, 2016
Dentium CAD/CAM Abutments
K161713
Dentium Co., Ltd.
Dental · 178d
Cleared Dec 15, 2016
IPS e.max® Press Abutment Solutions for Viteo Base Ti
K160798
Ivoclar Vivadent, AG
Dental · 267d
Cleared Dec 05, 2016
Transfer & Angled Abutment
K153015
Osstem Implant Co., Ltd.
Dental · 417d
Cleared Dec 05, 2016
PREMIUM Implant Systems SHELTA Implant Systems
K162004
Sweden & Martina S.P.A.
Dental · 138d
Cleared Nov 22, 2016
Temporary Snap Abutment
K161435
Nobel Biocare AB
Dental · 182d
Cleared Nov 21, 2016
Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
K160132
Hager& Meisinger GmbH
Dental · 306d
Cleared Nov 21, 2016
RODO Abutment System
K160786
Rodo Medical, Inc.
Dental · 244d
Cleared Nov 04, 2016
Inclusive Abutments
K160979
Prismatik Dentalcraft, Inc.
Dental · 211d
Cleared Oct 28, 2016
Link Abutment for CEREC
K160519
Osstem Implant Co., Ltd.
Dental · 246d
Cleared Oct 07, 2016
Straumann Sterile Healing Solution
K161677
Institut Straumann AG
Dental · 112d
Cleared Sep 29, 2016
CreoDent Solidex Custom Abutment
K160436
Creodent Prosthetics, Ltd.
Dental · 225d
Cleared Sep 21, 2016
ATLANTIS ISUS Implant Suprastructures
K160207
Dentsply International, Inc.
Dental · 237d
Cleared Sep 16, 2016
Neodent Implant System - Titanium Base for CEREC
K160964
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 163d
Cleared Sep 15, 2016
Dentium Implantium & SuperLine Prosthetics
K160828
Dentium Co., Ltd.
Dental · 174d
Cleared Sep 14, 2016
CAM Titanium Blanks
K160784
Altatec GmbH
Dental · 176d
Cleared Aug 29, 2016
ATLANTIS Abutment for HIOSSEN ET implant
K160626
Dentsply Sirona
Dental · 175d