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