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..

712
Total
712
Cleared
169d
Avg days
1993
Since
712 devices
385–408 of 712
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 17, 2010
HS/HG PROSTHETIC SYSTEM
K100245
Osstem Implant Co., Ltd.
Dental · 202d
Cleared Jun 24, 2010
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS
K093643
Nobel Biocare AB
Dental · 211d
Cleared Dec 22, 2009
STRAUMANN MODIFIED DENTAL ABUTMENT
K091701
Institut Straumann AG
Dental · 195d
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
Cleared Sep 25, 2009
NOBELPROCERA ZI ABUTMENT
K091904
Nobel Biocare AB
Dental · 92d
Cleared Sep 22, 2009
NOBELPROCERA TI ABUTMENT
K091756
Nobel Biocare AB
Dental · 98d
Cleared May 07, 2009
PROCERA IMPLANT BRIDGE OVERDENTURE
K090069
Nobel Biocare AB
Dental · 115d
Cleared Apr 07, 2009
HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
K090723
Zimmer Dental, Inc.
Dental · 29d
Cleared Dec 23, 2008
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
K083474
Zimmer Dental, Inc.
Dental · 29d
Cleared Dec 02, 2008
ZIOCERA & CONVERTIBLE SYSTEM
K081786
Osstem Implant Co., Ltd.
Dental · 161d
Cleared Oct 17, 2008
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
K082545
Institut Straumann AG
Dental · 44d
Cleared Oct 01, 2008
STRAUMANN WN CARES TITANIUM ABUTMENT
K082764
Institut Straumann AG
Dental · 9d
Cleared Sep 25, 2008
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
K080164
Zimmer Dental, Inc.
Dental · 246d
Cleared Sep 02, 2008
HU/HS/HG PROSTHETIC SYSTEM
K081575
Osstem Implant Co., Ltd.
Dental · 89d
Cleared May 23, 2008
CONCAVE RN HEALING CAP
K081186
Institut Straumann AG
Dental · 25d
Cleared May 02, 2008
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
K081005
Institut Straumann AG
Dental · 24d