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
457–480 of 713
Cleared Mar 29, 2013
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE
K124008
Ivoclar Vivadent, Agin
Dental · 92d
Cleared Mar 13, 2013
NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
K122602
Nobel Biocare AB
Dental · 198d
Cleared Jan 30, 2013
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
K113816
GC America, Inc.
Dental · 400d
Cleared Jan 23, 2013
OSSEOSPEED ANGLED ABUTMENT EV
K121810
Astra Tech AB
Dental · 217d
Cleared Dec 21, 2012
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST
K120822
Institut Straumann AG
Dental · 277d
Cleared Dec 14, 2012
NDX ABUTMENTS
K121117
National Dentex Corp
Dental · 246d
Cleared Dec 11, 2012
NP-CAST ABUTMENT SYSTEM
K121843
Osstem Implant Co., Ltd.
Dental · 169d
Cleared Dec 11, 2012
ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS
K122268
Dentsply International
Dental · 134d
Cleared Dec 10, 2012
INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
K121391
Prismatik Dentalcraft, Inc.
Dental · 215d
Cleared Dec 06, 2012
IMPLANT BAR
K120858
Prismatik Dentalcraft, Inc.
Dental · 260d
Cleared Nov 08, 2012
ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
K120873
Zimmer Dental, Inc.
Dental · 231d
Cleared Nov 02, 2012
NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
K122192
Straumann USA, LLC
Dental · 101d
Cleared Oct 19, 2012
ZFX DENTAL CAD SYSTEM
K121709
Zimmer Dental, Inc.
Dental · 130d
Cleared Oct 18, 2012
IPS E.MAX PRESS - ABUTMENT SOLUTIONS
K120053
Ivoclar Vivadent, AG
Dental · 286d
Cleared Oct 12, 2012
MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
K121688
Prismatik Dentalcraft, Inc.
Dental · 127d
Cleared Sep 11, 2012
ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION
K120776
Biomet 3i
Dental · 181d
Cleared Aug 14, 2012
VARIOECO
K121334
Thommen Medical AG
Dental · 103d
Cleared Aug 08, 2012
KERATOR
K112787
Kj Meditech Co., Ltd.
Dental · 317d
Cleared Jul 05, 2012
ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
K120338
Astra Tech, Inc.
Dental · 153d
Cleared Mar 01, 2012
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
K113003
Astra Tech, Inc.
Dental · 146d
Cleared Feb 17, 2012
SIRONA DENTAL CAD/CAM SYSTEM
K111421
Sirona Dental Systems GmbH
Dental · 273d
Cleared Feb 17, 2012
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
K111935
Nt-Trading GmbH and CO KG
Dental · 224d
Cleared Feb 03, 2012
CONTOUR HEALER
K112099
Contour Healer, LLC
Dental · 196d
Cleared Jan 30, 2012
LRT ATTACHMENT
K112333
Bcf Certification, Inc.
Dental · 171d