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, Terrats Medical SL and Dentsply Sirona.

706
Total
706
Cleared
169d
Avg days
1993
Since
Declining activity - 72 submissions in the last 2 years vs 93 in the prior period
Consistent review times: 176d avg (recent)

FDA 510(k) Cleared Abutment, Implant, Dental, Endosseous Devices (Product Code NHA)

706 devices
1–24 of 706
Cleared Jun 03, 2026
SIC Abutments including CAD/CAM Solutions
K252904
Sic Invent AG
Dental · 265d
Cleared May 20, 2026
Elos Accurate® Denture Fixation System
K253774
Elos Medtech Pinol A/S
Dental · 175d
Cleared May 14, 2026
ET Healing Abutments
K253372
Hiossen, Inc.
Dental · 226d
Cleared May 07, 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K260460
Institut Straumann AG
Dental · 85d
Cleared Apr 16, 2026
DESS Dental Smart Solutions
K253804
Terrats Medical SL
Dental · 139d
Cleared Apr 09, 2026
LOCATOR® Angled Abutment
K260555
Zest Anchors, LLC
Dental · 50d
Cleared Mar 04, 2026
Healing Abutment System
K251434
Osstem Implant Co., Ltd.
Dental · 300d
Cleared Feb 10, 2026
Solidex® Ti-Links and Screws
K251515
CreoDent Hudson Valley
Dental · 270d
Cleared Jan 29, 2026
Multi-Unit DAS System
K243732
Talladium Espa?a, SL
Dental · 421d
Cleared Jan 29, 2026
EK MULTI ANGLED 30 ABUTMENT
K251427
Hiossen, Inc.
Dental · 266d
Cleared Jan 22, 2026
IPDmilled Blanks
K253253
Implant Protesis Dental 2004, S.L.
Dental · 115d
Cleared Jan 22, 2026
Straumann Variobase Abutments XC for Bridge/Bar
K253315
Institut Straumann AG
Dental · 114d
Cleared Jan 07, 2026
Neodent InLab Validated Workflow
K252727
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental · 132d
Cleared Dec 23, 2025
OrangeCAD Med Abutments
K253312
Orangecad Med GmbH
Dental · 84d
Cleared Dec 23, 2025
Custom Abutments AS
K253341
Medentika GmbH
Dental · 84d
Cleared Dec 18, 2025
SIMDA Abutments
K252320
Simda Co., Ltd.
Dental · 146d
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 Oct 17, 2025
Adin Customized Abutments
K250178
Adin Dental Implant Systems , Ltd.
Dental · 268d
Cleared Oct 17, 2025
S.I.N. Dental Implant System
K252266
S.I.N. Implant System Ltda
Dental · 88d

About Product Code NHA - Regulatory Context

510(k) Submission Activity

706 total 510(k) submissions under product code NHA since 1993, with 706 receiving FDA clearance (average review time: 169 days).

Submission volume has declined in recent years - 72 submissions in the last 24 months compared to 93 in the prior period.

FDA 510(k) Review Time - NHA Product Code

FDA review times for NHA submissions have been consistent, averaging 176 days recently vs 169 days historically.

NHA devices are reviewed by the Dental panel. Browse all Dental devices →