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
625–648 of 713
Cleared Mar 07, 2005
ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE
K050052
Atlantis Components, Inc.
Dental · 56d
Cleared Dec 14, 2004
SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K043190
Innova Life Sciences Corp.
Dental · 27d
Cleared Nov 24, 2004
X-2 IMPLANT ABUTMENT
K042466
Zest Anchors, Inc.
Dental · 72d
Cleared Nov 18, 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K043042
Nobel Biocare AB
Dental · 14d
Cleared Oct 20, 2004
PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
K042658
Nobel Biocare Uas, Inc.
Dental · 22d
Cleared Jul 23, 2004
STRAUMANN TEMPORARY COPING
K041070
The Straumann Co.
Dental · 88d
Cleared May 27, 2004
PROCERA ABUTMENT OCTAGON
K041275
Nobel Biocare Uas, Inc.
Dental · 15d
Cleared May 26, 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K041236
Nobel Biocare AB
Dental · 15d
Cleared May 24, 2004
RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
K041295
Institut Straumann AG
Dental · 10d
Cleared Apr 28, 2004
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
K040573
Nobel Biocare Uas, Inc.
Dental · 55d
Cleared Mar 24, 2004
3I PATIENT-SPECIFIC OVERDENTURE BAR
K034035
Implant Innovations, Inc.
Dental · 86d
Cleared Mar 18, 2004
ELLIPTIC MATRIX
K040539
Institut Straumann AG
Dental · 16d
Cleared Feb 23, 2004
NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236
K033724
Nobel Biocare Uas, Inc.
Dental · 89d
Cleared Nov 03, 2003
SPI EASY DENTAL IMPLANT PROTECTIVE CAP
K033346
Thommen Medical AG
Dental · 14d
Cleared Oct 20, 2003
ITI SYNOCTA MESO ABUTMENTS
K033243
Straumann USA
Dental · 13d
Cleared Aug 27, 2003
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
K032498
Straumann USA
Dental · 14d
Cleared Jul 02, 2003
ESTHETIC ZIRCONIA ABUTMENT
K031719
Nobel Biocare AB
Dental · 29d
Cleared Jul 02, 2003
SPI DENTAL IMPLANT ABUTMENTS
K031747
Thommen Medical AG
Dental · 27d
Cleared Nov 13, 2002
SPI EASY DENTAL IMPLANT ABUTMENT
K023645
Thommen Medical AG
Dental · 14d
Cleared Nov 07, 2002
ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
K023631
Astra Tech, Inc.
Dental · 9d
Cleared Aug 30, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K022795
BioHorizons Implant Systems, Inc.
Dental · 7d
Cleared May 22, 2002
OCO DENTAL IMPLANT
K021460
"O" Co., Inc.
Dental · 15d
Cleared Jan 23, 1998
PROCERA PREPARABLE ABUTMENT SYSTEM
K974150
Nobel Biocare Uas, Inc.
Dental · 80d
Cleared Sep 12, 1997
AURADAPT AUBTMENT SYSTEM
K972475
Nobel Biocare Uas, Inc.
Dental · 73d