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 Terrats Medical SL.

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
481–504 of 713
Cleared Jan 27, 2012
NNC GOLD ABUTMENT FOR BRIDGES
K113606
Straumann USA
Dental · 52d
Cleared Jan 26, 2012
SIMPLELINE II ABUTMENT SYSTEM
K112045
Dentium Co., Ltd.
Dental · 192d
Cleared Jan 23, 2012
ZIMMER CONTOUR PROVISIONAL COPING
K113092
Zimmer Dental, Inc.
Dental · 96d
Cleared Jan 13, 2012
ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
K112730
Biomet 3i
Dental · 115d
Cleared Jan 13, 2012
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
K113410
Straumann USA
Dental · 56d
Cleared Dec 28, 2011
NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS
K113283
Straumann USA
Dental · 51d
Cleared Dec 08, 2011
ANGLED TAPERED ABUTMENT
K111853
Zimmer Dental, Inc.
Dental · 162d
Cleared Dec 01, 2011
ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
K112138
Astra Tech, Inc.
Dental · 128d
Cleared Nov 16, 2011
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
K112280
Straumann USA
Dental · 99d
Cleared Nov 10, 2011
SPI VARIO ANGLED ABUTMENT
K111984
Thommen Medical AG
Dental · 121d
Cleared Nov 04, 2011
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
K103291
BioHorizons Implant Systems, Inc.
Dental · 361d
Cleared Nov 03, 2011
BIOHORIZONS ABUTMENTS FOR ZIMMER
K103691
BioHorizons Implant Systems, Inc.
Dental · 321d
Cleared Oct 28, 2011
NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS
K112259
Nobel Biocare AB
Dental · 81d
Cleared Oct 03, 2011
PROSTHETIC SYSTEM
K110308
Osstem Implant Co., Ltd.
Dental · 243d
Cleared Sep 12, 2011
SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
K111390
Cendres & Metaux SA
Dental · 117d
Cleared Sep 01, 2011
ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE
K110565
Biomet 3i, Inc.
Dental · 185d
Cleared Aug 12, 2011
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
K110580
Straumann USA
Dental · 164d
Cleared Aug 11, 2011
ANODIZED HEALING COLLAR
K111852
Zimmer Dental, Inc.
Dental · 43d
Cleared Aug 08, 2011
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS
K111199
Intra-Lock International, Inc.
Dental · 102d
Cleared Jul 29, 2011
BIODENTA CUSTOMIZED ABUTMENT
K110778
Biodenta Swiss AG
Dental · 130d
Cleared Jun 30, 2011
GC AADVA BO AC ABUTMENTS
K103234
GC America, Inc.
Dental · 240d
Cleared Jun 23, 2011
15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE
K111581
Nobel Biocare AB
Dental · 16d
Cleared Jun 15, 2011
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
K110171
Nobel Biocare USA, LLC
Dental · 146d
Cleared Jun 10, 2011
ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
K110356
Astra Tech, Inc.
Dental · 123d