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