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
313–336 of 713
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 13, 2017
TSV BellaTek Encode Healing Abutments
K173374
Biomet 3i
Dental · 47d
Cleared Dec 01, 2017
Straumann n!ce Glass Ceramic A14 Blocks
K171773
Institut Straumann AG
Dental · 170d
Cleared Nov 30, 2017
Atlantis Abutment for MIS Implant
K172225
Dentsply Sirona
Dental · 128d
Cleared Nov 29, 2017
NobelDesign, DTX Studio Design
K171466
Nobel Biocare AB
Dental · 195d
Cleared Nov 29, 2017
s-Clean TiN Coating Abutments
K171694
Dentis Co., Ltd.
Dental · 175d
Cleared Nov 27, 2017
Straumann Screw Retained Abutments
K171757
Straumann USA, LLC (On Behalf of Institut Straumann Ag)
Dental · 166d
Cleared Nov 16, 2017
Klockner Vega TiBase for CEREC
K170022
SOADCO, S.L.
Dental · 317d
Cleared Nov 02, 2017
Neodent Implant System - CM Pro PEEK Abutment
K170080
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 296d
Cleared Oct 26, 2017
Healing Cap Multi-Unit Titanium
K171142
Nobel Biocare AB
Dental · 191d
Cleared Sep 28, 2017
Anatotemp Anatomic Dental Implant Healing Abutment
K171922
Buckeye Medical Technologies, LLC
Dental · 93d
Cleared Sep 22, 2017
Straumann CARES Golden Ti/TiN Abutments
K162848
Institut Straumann AG
Dental · 346d
Cleared Sep 21, 2017
Eztetic BellaTek Encode Healing Abutments
K170013
Biomet 3i
Dental · 261d
Cleared Sep 15, 2017
Medentika CAD/CAM TiBases
K170838
Medentika GmbH
Dental · 178d
Cleared Aug 17, 2017
Dentium NR Line CAD/CAM Abutments
K170384
Dentium Co., Ltd.
Dental · 191d
Cleared Aug 14, 2017
ATLANTIS suprastructures
K163398
Dentsply Sirona
Dental · 252d
Cleared Aug 08, 2017
DESS Dental Smart Solutions
K170588
Terrats Medical SL
Dental · 161d
Cleared Jul 24, 2017
Custom Bars
K162633
Implant Direct Sybron Manufacturing, LLC
Dental · 306d
Cleared Jul 18, 2017
CreoDent Solidex Customized Abutment and Screw
K170100
Creodent Prosthetics, Ltd.
Dental · 188d
Cleared Jun 07, 2017
Straumann Variobase Abutments
K170354
Institut Straumann AG
Dental · 121d
Cleared Jun 07, 2017
Straumann Variobase Abutments
K170356
Institut Straumann AG
Dental · 121d
Cleared Jun 06, 2017
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
K170044
Prismatik Dentalcraft, Inc.
Dental · 152d
Cleared May 25, 2017
TruAbutment DS
K170259
Truabutment
Dental · 118d