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 Zimmer Dental, Inc..

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
361–384 of 713
Cleared Aug 26, 2016
GPS Angled Abutment
K153509
Implant Direct Sybron Manufacturing, LLC
Dental · 263d
Cleared Aug 26, 2016
ATLANTIS Abutment for CONELOG implant
K161030
Dentsply Sirona
Dental · 135d
Cleared Aug 11, 2016
OT EQUATOR
K160382
Rhein 83 Srl
Dental · 183d
Cleared Aug 05, 2016
ArgenIS Titanium Abutments
K160248
Argen Corporation
Dental · 186d
Cleared Aug 05, 2016
Burn-out Cylinder and Angled Screw Abutments
K160483
Dentium Co., Ltd.
Dental · 165d
Cleared Jul 25, 2016
NobelProcera HT ML FCZ Implant Bridge and Framework
K160158
Nobel Biocare AB
Dental · 180d
Cleared Jun 30, 2016
VITA ENAMIC Implant Solutions (IS)
K153645
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 192d
Cleared Jun 02, 2016
NobelDesign Software
K153036
Nobel Biocare AB
Dental · 227d
Cleared Jun 02, 2016
VARIOunite
K160244
Thommen Medical AG
Dental · 122d
Cleared May 20, 2016
TruAbutment DS
K152559
Truabutment
Dental · 254d
Cleared Apr 15, 2016
Neodent Implant System
K153624
Jjgc Industria E Comercio DE Materiais Dentarios S
Dental · 119d
Cleared Apr 13, 2016
4plus6Line Abutment System
K151608
Ot Medical GmbH
Dental · 303d
Cleared Mar 31, 2016
Abutment for Bridges
K153779
Altatec GmbH
Dental · 91d
Cleared Mar 14, 2016
Allied Biocompat Abutment for Nobel Replace Interface
K152845
Allied Dental Solutions
Dental · 167d
Cleared Mar 10, 2016
Thommen Milling Abutment for CAD/CAM
K151984
Thommen Medical AG
Dental · 237d
Cleared Mar 04, 2016
Straumann RN Gold Abutment for Bridge
K151590
Straumann USA, LLC
Dental · 266d
Cleared Mar 04, 2016
LOCATOR F-Tx Attachment System
K151789
Zest Anchors, LLC
Dental · 247d
Cleared Feb 19, 2016
ATLANTIS ISUS
K151439
Dentsply International, Inc.
Dental · 266d
Cleared Jan 29, 2016
KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
K151194
SOADCO, S.L.
Dental · 270d
Cleared Jan 14, 2016
ATLANTIS Abutment for NobelActive 3.0
K151039
Dentsply International, Inc.
Dental · 269d
Cleared Jan 13, 2016
BioHorizons CAD/CAM Abutments
K151621
BioHorizons Implant Systems, Inc.
Dental · 211d
Cleared Jan 12, 2016
CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)
K152509
Altatec GmbH
Dental · 132d
Cleared Dec 01, 2015
Biodenta Customized Abutment - Titanium
K151295
Biodenta Swiss AG
Dental · 200d
Cleared Nov 25, 2015
OT EQUATOR
K142211
Rhein 83 Srl
Dental · 470d