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..

712
Total
712
Cleared
169d
Avg days
1993
Since
712 devices
337–360 of 712
Cleared Nov 16, 2015
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798
Prismatik Dentalcraft, Inc.
Dental · 137d
Cleared Oct 07, 2015
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
K151375
Prismatik Dentalcraft, Inc.
Dental · 138d
Cleared Oct 01, 2015
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
K143515
Prismatik Dentalcraft, Inc.
Dental · 294d
Cleared Jun 25, 2015
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
K143505
Zimmer Dental, Inc.
Dental · 197d
Cleared May 01, 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528
Zimmer Dental, Inc.
Dental · 140d
Cleared Jan 21, 2015
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
K142572
Zimmer Dental, Inc.
Dental · 131d
Cleared Jan 06, 2015
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
K141923
Prismatik Dentalcraft, Inc.
Dental · 174d
Cleared Nov 25, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE
K142118
Prismatik Dentalcraft, Inc.
Dental · 113d
Cleared Nov 13, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
K142115
Prismatik Dentalcraft, Inc.
Dental · 101d
Cleared Oct 22, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
K141211
Prismatik Dentalcraft, Inc.
Dental · 166d
Cleared Oct 22, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
K141544
Zimmer Dental, Inc.
Dental · 134d
Cleared Aug 21, 2014
SB ANCHOR
K140600
Osstem Implant Co., Ltd.
Dental · 164d
Cleared Aug 20, 2014
HIOSSEN PROSTHETIC SYSTEM
K140507
Osstem Implant Co., Ltd.
Dental · 174d
Cleared Jul 29, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
K141120
Zimmer Dental, Inc.
Dental · 90d
Cleared Jul 18, 2014
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
K133551
Zimmer Dental, Inc.
Dental · 241d
Cleared Apr 25, 2014
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM
K134045
Zimmer Dental, Inc.
Dental · 115d
Cleared Apr 04, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
K133377
Nobel Biocare AB
Dental · 151d
Cleared Jan 22, 2014
ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
K131644
Dentsply International, Inc.
Dental · 231d
Cleared Jan 10, 2014
ET PROSTHETIC SYSTEM
K130662
Osstem Implant Co., Ltd.
Dental · 304d
Cleared Jul 05, 2013
ISUS IMPLANT SUPRASTRUCTURES
K122424
Dentsply International, Inc.
Dental · 330d
Cleared Jun 28, 2013
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
K130808
Straumann USA
Dental · 95d
Cleared Jun 05, 2013
NOBELPROCERA PEEK ABUTMENTS
K120954
Nobel Biocare AB
Dental · 432d
Cleared Apr 26, 2013
MULTI ANGLED ABUTMENT
K123755
Osstem Implant Co., Ltd.
Dental · 140d
Cleared Mar 13, 2013
NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
K122602
Nobel Biocare AB
Dental · 198d