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 Terrats Medical SL, Institut Straumann AG and Dentis Co., Ltd..

702
Total
702
Cleared
169d
Avg days
1993
Since
702 devices
121–144 of 702
Cleared Mar 22, 2023
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
K221402
Dentsply Sirona, Inc.
Dental · 310d
Cleared Mar 09, 2023
DESS Dental Smart Solutions
K221301
Terrats Medical SL
Dental · 308d
Cleared Feb 07, 2023
SAVE GBR
K222451
Dentis Co., Ltd.
Dental · 176d
Cleared Jan 13, 2023
s-Clean Link Abutment
K222913
Dentis Co., Ltd.
Dental · 109d
Cleared Jan 12, 2023
MU System
K222976
Dentis Co., Ltd.
Dental · 106d
Cleared Nov 10, 2022
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
K220562
Megagen Implant Co., Ltd.
Dental · 255d
Cleared Oct 27, 2022
DESS Dental Smart Solutions
K222288
Terrats Medical SL
Dental · 90d
Cleared Oct 26, 2022
DESS Dental Smart Solutions
K222269
Terrats Medical SL
Dental · 90d
Cleared Sep 08, 2022
Osstem Abutment System
K221684
Osstem Implant Co., Ltd.
Dental · 90d
Cleared Jun 16, 2022
Dentis s-Clean Abutment Mini
K220440
Dentis Co., Ltd.
Dental · 120d
Cleared Jun 16, 2022
Straumann TLX Variobase C
K220878
Institut Straumann AG
Dental · 83d
Cleared Jun 02, 2022
Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
K220751
Institut Straumann AG
Dental · 79d
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 Feb 03, 2022
Healing Abutment, Cover Screw
K210826
Megagen Implant Co., Ltd.
Dental · 321d
Cleared Dec 10, 2021
DESS Dental Smart Solutions
K212577
Terrats Medical SL
Dental · 116d
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 10, 2021
s-Clean Pre-Milled Abutment Mini
K210410
Dentis Co., Ltd.
Dental · 211d
Cleared Aug 19, 2021
s-Clean Pre-Milled Abutment
K210362
Dentis Co., Ltd.
Dental · 192d
Cleared Aug 04, 2021
DESS Dental Smart Solutions
K203464
Terrats Medical SL
Dental · 253d
Cleared Aug 02, 2021
Neodent Implant System - Mini Abutment 60°
K203542
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 242d