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
289–312 of 706
Cleared May 23, 2018
Rodo Smilekey
K180609
Rodo Medical, Inc.
Dental · 76d
Cleared May 18, 2018
ArgenIS Titanium Abutments
K172430
Argen Corporation
Dental · 280d
Cleared May 14, 2018
Dentium Implantium & SuperLine Prosthetics
K172640
Dentium Co., Ltd.
Dental · 255d
Cleared May 04, 2018
3.0 Dynamic TiBase
K162021
Talladium Espana, SL
Dental · 652d
Cleared Apr 20, 2018
Neodent Implant System – GM Line
K173902
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 119d
Cleared Apr 09, 2018
OT EQUATOR
K171409
Rhein 83 Srl
Dental · 329d
Cleared Mar 30, 2018
Straumann Variobase for Crown AS
K173379
Institut Straumann AG
Dental · 151d
Cleared Mar 16, 2018
CCM Abutment System
K173120
Innobiosurg Co., Ltd.
Dental · 168d
Cleared Mar 16, 2018
MIS CONNECT Conical Connection Abutment
K173326
Mis Implants Technologies , Ltd.
Dental · 147d
Cleared Feb 22, 2018
Straumann CARES M-Series CAD/CAM System
K171649
Institut Straumann AG
Dental · 262d
Cleared Feb 09, 2018
Southern Implants PEEK Abutments
K172160
Southern Implants (Pty), Ltd.
Dental · 206d
Cleared Feb 01, 2018
PREMIUM Implant Systems SHELTA Implant Systems
K161989
Sweden & Martina S.P.A.
Dental · 562d
Cleared Jan 26, 2018
Panthera Dental Milled Bars
K173466
Panthera Dental, Inc.
Dental · 79d
Cleared Jan 23, 2018
TruAbutment DS
K172304
Truabutment, Inc.
Dental · 176d
Cleared Jan 15, 2018
Elos Accurate Customized Abutment, Elos Prosthetic Screw
K171799
Elos Medtech Pinol A/S
Dental · 213d
Cleared Jan 11, 2018
ET Hybrid Abutment
K170421
Hiossen, Inc.
Dental · 332d
Cleared Jan 11, 2018
Dentium Ti-Base
K171622
Dentium Co., Ltd.
Dental · 223d
Cleared Jan 03, 2018
Straumann CARES Abutments CoCr
K172798
Institut Straumann AG
Dental · 107d
Cleared Dec 14, 2017
NobelPerfect Abutments
K172854
Nobel Biocare AB
Dental · 85d
Cleared Dec 01, 2017
Straumann n!ce Glass Ceramic A14 Blocks
K171773
Institut Straumann AG
Dental · 170d
Cleared Nov 29, 2017
NobelDesign, DTX Studio Design
K171466
Nobel Biocare AB
Dental · 195d
Cleared Oct 26, 2017
Healing Cap Multi-Unit Titanium
K171142
Nobel Biocare AB
Dental · 191d
Cleared Sep 22, 2017
Straumann CARES Golden Ti/TiN Abutments
K162848
Institut Straumann AG
Dental · 346d
Cleared Jun 07, 2017
Straumann Variobase Abutments
K170354
Institut Straumann AG
Dental · 121d