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
265–288 of 706
Cleared Jun 26, 2019
Straumann CARES Screw-Retained Bridges and Bars
K190097
Institut Straumann AG
Dental · 155d
Cleared Jun 26, 2019
Elos Accurate® Customized Abutment
K190299
Elos Medtech Pinol A/S
Dental · 135d
Cleared Jun 20, 2019
Panthera Dental Milled Bars
K183580
Panthera Dental, Inc.
Dental · 181d
Cleared May 17, 2019
SD Abutment
K173570
Surgident Co., Ltd.
Dental · 543d
Cleared Apr 17, 2019
Straumann BLX Variobase Abutment
K190082
Institut Straumann AG
Dental · 90d
Cleared Apr 16, 2019
MIST IC
K182246
Imagine Milling Technologies, LLC
Dental · 239d
Cleared Apr 08, 2019
Straumann BLX Line Extension - New Abutments
K190040
Institut Straumann AG
Dental · 90d
Cleared Mar 18, 2019
Preat Abutments
K183518
Preat Corporation
Dental · 90d
Cleared Jan 29, 2019
Cortex CAD/CAM Abutments
K181580
Cortex Dental Implants Industries , Ltd.
Dental · 228d
Cleared Jan 28, 2019
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
K182228
Mis Implants Technologies , Ltd.
Dental · 165d
Cleared Jan 07, 2019
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
K180564
Medentika GmbH
Dental · 308d
Cleared Dec 21, 2018
DIO CAD/CAM Abutment
K181037
Dio Corporation
Dental · 246d
Cleared Dec 12, 2018
On1 Universal Abutment
K181869
Nobel Biocare AB
Dental · 153d
Cleared Nov 23, 2018
A.B. Dental Devices Dental Implants System
K181381
A.B. Dental Device , Ltd.
Dental · 183d
Cleared Nov 16, 2018
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
K180184
Dentalpoint AG
Dental · 297d
Cleared Oct 31, 2018
Universal Base Abutment
K180899
Nobel Biocare AB
Dental · 208d
Cleared Oct 11, 2018
Sirona Dental CAD/CAM System
K181520
Dentsply Sirona
Dental · 122d
Cleared Oct 05, 2018
Straumann SC Variobase Abutments
K173945
Institut Straumann AG
Dental · 283d
Cleared Sep 28, 2018
BioHorizons CAD/CAM Bars
K180998
BioHorizons Implant Systems, Inc.
Dental · 165d
Cleared Sep 11, 2018
TruBase S
K171532
Truabutment, Inc.
Dental · 474d
Cleared Aug 15, 2018
InterActive SMARTBase Abutments
K181359
Implant Direct Sybron Manufacturing, LLC
Dental · 85d
Cleared Jul 18, 2018
ATLANTIS Conus Structure
K181189
Dentsply Sirona
Dental · 76d
Cleared Jul 17, 2018
Straumann Variobase for Bridge/Bar Cylindrical
K173968
Institut Straumann AG
Dental · 200d
Cleared Jun 15, 2018
DESS Dental Smart Solutions
K173908
Terrats Medical SL
Dental · 175d