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, Terrats Medical SL and Dentsply Sirona.

706
Total
706
Cleared
169d
Avg days
1993
Since
706 devices
217–240 of 706
Cleared Oct 27, 2020
TIB Abutment System
K193084
Southern Implants (Pty), Ltd.
Dental · 357d
Cleared Sep 02, 2020
LOCATOR R-Tx
K200827
Ivory Super Holdco, Incp.
Dental · 156d
Cleared Aug 19, 2020
Straumann BLX Gold Abutments
K200597
Straumann USA, LLC (On Behalf of Institut Straumann Ag)
Dental · 163d
Cleared Aug 16, 2020
Sirona Dental CAD/CAM System with CEREC Chairside Software
K193408
Dentsply Sirona
Dental · 251d
Cleared Aug 13, 2020
Straumann® Retentive System – Novaloc TiN Abutments
K193046
Institut Straumann AG
Dental · 286d
Cleared Jul 22, 2020
Duranext Abutments
K200355
Elegant Dental Corp.
Dental · 160d
Cleared Jul 15, 2020
Magicore II System
K201621
Innobiosurg Co., Ltd.
Dental · 30d
Cleared Jul 06, 2020
MIS Ti-base Abutment
K191152
Dentsply Sirona
Dental · 432d
Cleared Jun 19, 2020
TruAbutment DS
K191913
Truabutment, Inc.
Dental · 338d
Cleared Jun 09, 2020
IBS Implant System II
K200753
Innobiosurg Co., Ltd.
Dental · 78d
Cleared May 18, 2020
UF(II) Bar holder abutment
K193404
Dio Corporation
Dental · 164d
Cleared May 08, 2020
Custom Legacy and Custom InterActive Titanium Abutments
K192218
Implant Direct Sybron Manufacturing, LLC
Dental · 267d
Cleared Apr 08, 2020
Panthera Dental Milled Bars
K192108
Panthera Dental, Inc.
Dental · 247d
Cleared Apr 06, 2020
Straumann Screw-Retained Abutments
K192401
Straumann USA, LLC
Dental · 216d
Cleared Mar 30, 2020
Universal Base Conical Connection (CC)
K200040
Nobel Biocare AG
Dental · 82d
Cleared Mar 25, 2020
MIS CONNECT Conical Connection System
K193078
Dentsply Sirona
Dental · 141d
Cleared Mar 24, 2020
Sherlock
K193335
Open Implants, LLC
Dental · 113d
Cleared Mar 09, 2020
Pre-Milled Blank
K193425
Arum Dentistry Co., Ltd.
Dental · 90d
Cleared Mar 05, 2020
ATLANTIS Abutment for MIS Conical Connection Implants
K193529
Dentsply Sirona
Dental · 76d
Cleared Mar 03, 2020
Atlantis suprastructures
K193064
Dentsply Sirona, Inc.
Dental · 120d
Cleared Feb 27, 2020
Rodo Abutment System
K193274
Rodo Medical, Inc.
Dental · 93d
Cleared Feb 26, 2020
Luna Dental Implant System- Healing Abutment
K200189
Shinhung Mst Co., Ltd.
Dental · 30d
Cleared Feb 21, 2020
UCLA CCM Abutment
K192263
Dio Corporation
Dental · 184d
Cleared Feb 13, 2020
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
K192614
Megagen Implant Co., Ltd.
Dental · 143d