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
505–528 of 713
Cleared Jun 10, 2011
ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
K110640
Astra Tech, Inc.
Dental · 98d
Cleared Apr 20, 2011
SPI TITANIUM BASE FOR CAD/CAM
K102804
Thommen Medical AG
Dental · 205d
Cleared Apr 08, 2011
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
K103759
Astra Tech, Inc.
Dental · 106d
Cleared Mar 31, 2011
TDS ABUTMENT FOR FRIADENT XIVE
K103339
Pou YU Biotechnology Co., Ltd.
Dental · 136d
Cleared Feb 24, 2011
BHDENTAL IMPLANT SYSTEM
K103280
Bhdental, Ltd.
Dental · 111d
Cleared Feb 03, 2011
ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
K103020
Atlantis Components, Inc.
Dental · 114d
Cleared Jan 10, 2011
CAMLOG VARIO SR ABUTMENTS
K103252
Altatec GmbH
Dental · 68d
Cleared Dec 28, 2010
INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS
K100993
Prismatik Dentalcraft, Inc.
Dental · 263d
Cleared Dec 13, 2010
STRAUMANN CARES BRIDGE
K101465
Institut Straumann AG
Dental · 201d
Cleared Oct 22, 2010
SIRONA CAD/CAM SYSTEM
K100152
Sirona Dental Systems GmbH
Dental · 276d
Cleared Sep 09, 2010
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
K100985
BioHorizons Implant Systems, Inc.
Dental · 153d
Cleared Aug 31, 2010
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
K101714
Nobel Biocare AB
Dental · 74d
Cleared Aug 19, 2010
SPI VARIOMULTI ANGLED ABUTMENT
K101798
Thommen Medical AG
Dental · 52d
Cleared Aug 17, 2010
HS/HG PROSTHETIC SYSTEM
K100245
Osstem Implant Co., Ltd.
Dental · 202d
Cleared Aug 16, 2010
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT
K101004
Astra Tech, Inc.
Dental · 126d
Cleared Jun 24, 2010
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS
K093643
Nobel Biocare AB
Dental · 211d
Cleared Apr 16, 2010
ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT
K093780
Astra Tech, Inc.
Dental · 128d
Cleared Dec 22, 2009
STRAUMANN MODIFIED DENTAL ABUTMENT
K091701
Institut Straumann AG
Dental · 195d
Cleared Dec 22, 2009
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT
K093483
Astra Tech, Inc.
Dental · 43d
Cleared Dec 18, 2009
ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
K093113
Institut Straumann AG
Dental · 78d
Cleared Nov 03, 2009
PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
K092377
Zimmer Dental, Inc.
Dental · 90d
Cleared Oct 30, 2009
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
K092403
Zimmer Dental, Inc.
Dental · 85d
Cleared Oct 16, 2009
NOBEL/PROCERA IMPLANT BRIDGE
K091848
Nobel Biocare AB
Dental · 116d
Cleared Oct 06, 2009
NOBELPROCERA IMPLANT BRIDGE ZIRCONIA
K091907
Nobel Biocare AB
Dental · 103d