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.

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
409–432 of 713
Cleared Jan 21, 2015
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
K142572
Zimmer Dental, Inc.
Dental · 131d
Cleared Jan 09, 2015
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
K142890
Straumann USA, LLC
Dental · 98d
Cleared Jan 06, 2015
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
K141923
Prismatik Dentalcraft, Inc.
Dental · 174d
Cleared Dec 24, 2014
Straight Stud Attachment
K142407
Sterngold Dental, LLC
Dental · 118d
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 Nov 12, 2014
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
K141457
Dentium Co., Ltd.
Dental · 163d
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 Aug 14, 2014
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
K140737
Straumann USA, LLC
Dental · 143d
Cleared Aug 07, 2014
Straumann Bone Level NC Angled Screw Retained Abutments
K141871
Straumann USA, LLC
Dental · 27d
Cleared Jul 29, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
K141120
Zimmer Dental, Inc.
Dental · 90d
Cleared Jul 24, 2014
NOBELPROCERA OVERDENTURE BAR
K132749
Nobel Biocare USA, LLC
Dental · 324d
Cleared Jul 18, 2014
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
K133551
Zimmer Dental, Inc.
Dental · 241d
Cleared Jul 07, 2014
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
K132214
Hager& Meisinger GmbH
Dental · 356d
Cleared May 06, 2014
DENRACLE DENTAL ABUTMENT
K131468
Green Dentech Co, Ltd.
Dental · 350d
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 17, 2014
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
K133421
Straumann USA, LLC
Dental · 160d
Cleared Apr 16, 2014
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
K133791
Sterngold Dental, LLC
Dental · 124d
Cleared Apr 04, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
K133377
Nobel Biocare AB
Dental · 151d
Cleared Mar 03, 2014
SFI-ANCHOR
K130618
Cendres & Metaux SA
Dental · 361d
Cleared Feb 25, 2014
SFI-BAR IMPLANT ABUTMENTS
K132814
Sterngold Dental, LLC
Dental · 169d