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
169–192 of 706
Cleared Jun 06, 2022
PrimeLOC Attachment System
K220612
Innovative Product Brands, Inc.
Dental · 95d
Cleared Jun 02, 2022
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
K220751
Institut Straumann AG
Dental · 79d
Cleared May 17, 2022
Neoss Individual Prosthetics
K211396
Neoss, Ltd.
Dental · 377d
Cleared Apr 14, 2022
High Retention Attachment System
K220252
Zest Anchors, LLC
Dental · 73d
Cleared Apr 08, 2022
TLX SRAs and TLX Gold Abutments
K213063
Institut Straumann AG
Dental · 197d
Cleared Apr 01, 2022
MIS Angulated multi-unit abutments
K213432
Dentsply Sirona
Dental · 161d
Cleared Mar 11, 2022
DESS Dental Smart Solutions
K212628
Terrats Medical SL
Dental · 204d
Cleared Mar 03, 2022
Osteon Precision Milled Suprastructure
K212676
Implant Solutions Pty Ltd (Osteon Medical)
Dental · 191d
Cleared Feb 04, 2022
Noris Medical Dental Implants System
K210356
Noris Medical , Ltd.
Dental · 361d
Cleared Feb 03, 2022
Healing Abutment, Cover Screw
K210826
Megagen Implant Co., Ltd.
Dental · 321d
Cleared Jan 25, 2022
INNO SLA Submerged Implant System
K201323
Cowellmedi Co., Ltd.
Dental · 617d
Cleared Jan 11, 2022
High Retention Attachment System
K213391
Zest Anchors, LLC
Dental · 88d
Cleared Dec 21, 2021
BellaTek Encode Emergence Healing Abutments
K212730
Biomet 3i, LLC
Dental · 113d
Cleared Dec 10, 2021
DESS Dental Smart Solutions
K212577
Terrats Medical SL
Dental · 116d
Cleared Nov 30, 2021
Sherlock
K212664
Open Implants, LLC
Dental · 99d
Cleared Nov 18, 2021
FAICO Dental Implant System and CAD/CAM Abutments
K211871
Faico Medical, LLC
Dental · 154d
Cleared Nov 15, 2021
DS Implants abutments provided with the EV connection
K213449
Dentsply Sirona
Dental · 20d
Cleared Oct 20, 2021
Multi-unit Abutment, Multi-unit Angled Abutment
K203808
Megagen Implant Co., Ltd.
Dental · 296d
Cleared Oct 09, 2021
Straumann CARES P-Series CAD/CAM System
K203750
Institut Straumann AG
Dental · 290d
Cleared Sep 24, 2021
Dynamic TiBase
K212108
Talladium Espa?a, SL
Dental · 80d
Cleared Sep 15, 2021
TruAbutment DS, TruBase
K203649
Truabutment, Inc.
Dental · 275d
Cleared Sep 10, 2021
s-Clean Pre-Milled Abutment Mini
K210410
Dentis Co., Ltd.
Dental · 211d
Cleared Aug 25, 2021
Premilled Titanium Block System
K203344
Innobiosurg Co., Ltd.
Dental · 285d
Cleared Aug 19, 2021
s-Clean Pre-Milled Abutment
K210362
Dentis Co., Ltd.
Dental · 192d