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
Cleared
Jan 21, 2015
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
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
Straumann USA, LLC
Dental
98d
Cleared
Jan 06, 2015
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
Prismatik Dentalcraft, Inc.
Dental
174d
Cleared
Dec 24, 2014
Straight Stud Attachment
Sterngold Dental, LLC
Dental
118d
Cleared
Nov 25, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE
Prismatik Dentalcraft, Inc.
Dental
113d
Cleared
Nov 13, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
Prismatik Dentalcraft, Inc.
Dental
101d
Cleared
Nov 12, 2014
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
Dentium Co., Ltd.
Dental
163d
Cleared
Oct 22, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
Prismatik Dentalcraft, Inc.
Dental
166d
Cleared
Oct 22, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
Zimmer Dental, Inc.
Dental
134d
Cleared
Aug 21, 2014
SB ANCHOR
Osstem Implant Co., Ltd.
Dental
164d
Cleared
Aug 20, 2014
HIOSSEN PROSTHETIC SYSTEM
Osstem Implant Co., Ltd.
Dental
174d
Cleared
Aug 14, 2014
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
Straumann USA, LLC
Dental
143d
Cleared
Aug 07, 2014
Straumann Bone Level NC Angled Screw Retained Abutments
Straumann USA, LLC
Dental
27d
Cleared
Jul 29, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
Zimmer Dental, Inc.
Dental
90d
Cleared
Jul 24, 2014
NOBELPROCERA OVERDENTURE BAR
Nobel Biocare USA, LLC
Dental
324d
Cleared
Jul 18, 2014
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
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
Hager& Meisinger GmbH
Dental
356d
Cleared
May 06, 2014
DENRACLE DENTAL ABUTMENT
Green Dentech Co, Ltd.
Dental
350d
Cleared
Apr 25, 2014
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM
Zimmer Dental, Inc.
Dental
115d
Cleared
Apr 17, 2014
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
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]
Sterngold Dental, LLC
Dental
124d
Cleared
Apr 04, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
Nobel Biocare AB
Dental
151d
Cleared
Mar 03, 2014
SFI-ANCHOR
Cendres & Metaux SA
Dental
361d
Cleared
Feb 25, 2014
SFI-BAR IMPLANT ABUTMENTS
Sterngold Dental, LLC
Dental
169d