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
169–192 of 713
Cleared Aug 10, 2022
KDG Abutments
K221381
Keystone Dental, Inc.
Dental · 89d
Cleared Jul 29, 2022
NobelProcera Zirconia N1 Base
K220048
Nobel Biocare Services AG
Dental · 204d
Cleared Jul 14, 2022
TruAbutment DS, TruBase
K213961
Truabutment, Inc.
Dental · 206d
Cleared Jul 05, 2022
Osteon Precision Milled Suprastructure
K221019
Implant Solutions Pty Ltd (Aka Osteon Medical)
Dental · 90d
Cleared Jun 21, 2022
Sherlock
K220482
Open Implants, LLC
Dental · 123d
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 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