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 Terrats Medical SL.

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
49–72 of 713
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
Cleared Jan 03, 2025
NobelProcera Zirconia Implant Bridge
K240346
Nobel Biocare AB
Dental · 333d
Cleared Dec 19, 2024
IPD Dental Implant Abutments
K242819
Implant Protesis Dental 2004, S.L.
Dental · 92d
Cleared Dec 17, 2024
ALLONUS Tech Prosthetics
K241616
Allonus Tech Co., Ltd.
Dental · 195d
Cleared Dec 10, 2024
Elos Accurate® Hybrid Base™
K242025
Elos Medtech Pinol A/S
Dental · 152d
Cleared Dec 05, 2024
LW Pre-milled Abutment
K242703
Ossvis Co., Ltd.
Dental · 87d
Cleared Dec 04, 2024
Neodent Implant System
K242686
Jjgc Ind?stria E Com?rcia DE Materiais Dent?rios S.A.
Dental · 89d
Cleared Nov 25, 2024
Customized Abutment
K242245
Arum Dentistry Co., Ltd.
Dental · 117d
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 Oct 21, 2024
Dynamic TiBase
K241170
Talladium Espa?a, SL
Dental · 178d
Cleared Oct 18, 2024
PreXolid CAD/CAM abutments
K240725
Eclectic Co., Ltd.
Dental · 214d
Cleared Oct 09, 2024
TruAbutment DS
K241485
Truabutment, Inc.
Dental · 138d
Cleared Sep 18, 2024
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
K234142
Megagen Implant Co., Ltd.
Dental · 264d