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
Declining activity - 71 submissions in the last 2 years vs 93 in the prior period
Consistent review times: 173d avg (recent)

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

713 devices
1–24 of 713
Cleared Aug 06, 2026
Universal Base ASC Engaging
K253999
Nobel Biocare AB
Dental · 234d
Cleared Jul 01, 2026
Neodent Implant System - NeoConvert Fit
K261147
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental · 85d
Cleared Jun 27, 2026
MIST IC
K261122
Imagine Milling Technologies, LLC
Dental · 85d
Cleared Jun 26, 2026
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)
K260061
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Jun 15, 2026
Neodent Scannable Healing Abutment
K253922
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental · 189d
Cleared Jun 11, 2026
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
K254145
Smart Denture Conversions, LLC
Dental · 171d
Cleared Jun 09, 2026
DESS Dental Smart Solutions
K260564
Terrats Medical SL
Dental · 110d
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

About Product Code NHA - Regulatory Context

510(k) Submission Activity

713 total 510(k) submissions under product code NHA since 1993, with 713 receiving FDA clearance (average review time: 169 days).

Submission volume has declined in recent years - 71 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 173 days recently vs 169 days historically.

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