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..

80
Total
80
Cleared
174d
Avg days
2021
Since

List of Abutment, Implant, Dental, Endosseous devices cleared through 510(k)

80 devices
1–24 of 80
Cleared Mar 04, 2026
Healing Abutment System
K251434
Osstem Implant Co., Ltd.
Dental · 300d
Cleared Jan 29, 2026
EK MULTI ANGLED 30 ABUTMENT
K251427
Hiossen, Inc.
Dental · 266d
Cleared Jan 22, 2026
Straumann Variobase Abutments XC for Bridge/Bar
K253315
Institut Straumann AG
Dental · 114d
Cleared Dec 09, 2025
Atlantis® Abutments in Titanium
K252343
Dentsply Sirona
Dental · 134d
Cleared Nov 26, 2025
CEREC Tessera Abutment System
K252248
Dentsply Sirona
Dental · 131d
Cleared Nov 21, 2025
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants
K251205
Dentsply Sirona
Dental · 217d
Cleared Nov 18, 2025
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
K252582
Prismatik Dentalcraft, Inc.
Dental · 95d
Cleared Oct 31, 2025
DESS Dental Smart Solutions
K251547
Terrats Medical SL
Dental · 163d
Cleared Oct 23, 2025
DESS® Dental Smart Solutions
K252384
Terrats Medical SL
Dental · 84d
Cleared May 22, 2025
DESS Dental Smart Solutions
K250639
Terrats Medical SL
Dental · 80d
Cleared May 01, 2025
Conical Ti Base abutments
K243521
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Apr 30, 2025
Dentsply Sirona Titanium Bases system
K250295
Dentsply Sirona
Dental · 89d
Cleared Apr 11, 2025
Atlantis® Abutments in Titanium
K250081
Dentsply Sirona
Dental · 88d
Cleared Feb 21, 2025
Custom Abutments
K243278
Institut Straumann AG
Dental · 128d
Cleared Feb 19, 2025
Straumann InLab Validated Workflow
K243478
Institut Straumann AG
Dental · 103d
Cleared Feb 14, 2025
DESS Dental Smart Solutions
K243212
Terrats Medical SL
Dental · 135d
Cleared Jan 13, 2025
MegaGen Dental Implant Abutment
K242030
Megagen Implant Co., Ltd.
Dental · 186d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003
Hiossen, Inc.
Dental · 271d
Cleared Jan 03, 2025
NobelProcera Zirconia Implant Bridge
K240346
Nobel Biocare AB
Dental · 333d
Cleared Nov 11, 2024
Straumann® Anatomic Healing Abutments XC (AHA)
K241575
Straumann USA, LLC
Dental · 161d
Cleared Nov 05, 2024
DESS Dental Smart Solutions
K242340
Terrats Medical SL
Dental · 90d
Cleared Sep 18, 2024
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
K234142
Megagen Implant Co., Ltd.
Dental · 264d
Cleared Aug 26, 2024
DESS Dental Smart Solutions
K240982
Terrats Medical SL
Dental · 138d
Cleared Jul 30, 2024
SmartShape™ Healing Abutment
K240531
BioHorizons Implant Systems, Inc.
Dental · 158d

How to use this database

This page lists all FDA 510(k) submissions for Abutment, Implant, Dental, Endosseous devices (product code NHA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Dental FDA review panel. Browse all Dental devices →