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.

716
Total
716
Cleared
169d
Avg days
1993
Since
716 devices
265–288 of 716
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
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