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
25–48 of 702
Cleared Sep 02, 2025
Customized Abutment and Screw
K242768
Chengdu Besmile Medical Technology Co., Ltd.
Dental · 354d
Cleared Aug 20, 2025
LOCATOR® Angled Abutment
K250721
Zest Anchors, LLC
Dental · 163d
Cleared Aug 20, 2025
IPD Dental Implant Abutments
K251471
Implant Protesis Dental 2004, S.L.
Dental · 99d
Cleared Jul 28, 2025
ISO Abutment
K241183
Seum Medi Co., Ltd.
Dental · 455d
Cleared Jul 28, 2025
NUVENTUS NV.C™ Prosthetic Components
K251220
Infinitum Eta, Ltd.
Dental · 98d
Cleared Jun 26, 2025
Sherlock
K250967
Open Implants, LLC
Dental · 87d
Cleared Jun 24, 2025
MIST IC
K243009
Imagine Milling Technologies, LLC
Dental · 271d
Cleared Jun 16, 2025
Geo Abutment
K242978
Geomedi Co,., Ltd.
Dental · 263d
Cleared May 30, 2025
Dynamic TiBase
K243530
Talladium Espa?a, SL
Dental · 197d
Cleared May 27, 2025
Neodent Implant System - Custom Abutments
K250614
Jjgc Ind?stria E Com?rcia DE Materiais Dent?rios S.A.
Dental · 88d
Cleared May 22, 2025
DESS Dental Smart Solutions
K250639
Terrats Medical SL
Dental · 80d
Cleared May 08, 2025
Preat Abutments
K243824
Preat Corporation
Dental · 147d
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 22, 2025
Medentika CAD/CAM Abutments
K242542
Medentika GmbH
Dental · 239d
Cleared Apr 11, 2025
Atlantis® Abutments in Titanium
K250081
Dentsply Sirona
Dental · 88d
Cleared Mar 04, 2025
iPhysio® System
K232383
Euroteknika
Dental · 574d
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 17, 2025
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)
K242064
Smart Denture Conversions, LLC
Dental · 186d
Cleared Jan 14, 2025
LOCATOR Angled Abutment
K243272
Zest Anchors, LLC
Dental · 90d
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