Ek Multi Angled 30 Abutment

FDA 510(k) K251427 · Hiossen, Inc.

Substantially Equivalent

510(k) numberK251427

Submission

Device name
Ek Multi Angled 30 Abutment
Applicant
Hiossen, Inc.
Fairless Hills, PA, US
Received
May 8, 2025
Decision date
January 29, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional Nobel Biocare AB08/06/2026SE
K261147Neodent Implant System - NeoConvert FitNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…07/01/2026SE
K261122Mist IcNHA · Traditional Imagine Milling Technologies, LLC06/27/2026SE
K260061BioHorizons CEREC Compatible Ti-BasesNHA · Traditional BioHorizons Implant Systems, Inc.06/26/2026SE
K253922Neodent Scannable Healing AbutmentNHA · Traditional JJGC Indústria e Comércio de Materiais Dentários…06/15/2026SE
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)NHA · Abbreviated Smart Denture Conversions, LLC06/11/2026SE
K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
K252904SIC Abutments including CAD/CAM SolutionsNHA · Traditional Sic Invent AG06/03/2026SE
K253774Elos Accurate® Denture Fixation SystemNHA · Traditional Elos Medtech Pinol A/S05/20/2026SE
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional Hiossen, Inc.05/14/2026SE

More from Hiossen, Inc.

510(k)DeviceDecision
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional 05/14/2026SE
K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)NHA · Abbreviated 01/08/2025SE
K240232EK D3.3 and Ultra Wide ImplantsDZE · Traditional 09/13/2024SE
K233389EK Digital AbutmentsNHA · Traditional 05/29/2024SE
K222636ET Abutment SystemNHA · Traditional 04/28/2023SE
K203360EK Implants and Abutments SystemDZE · Traditional 01/07/2022SE
K191751EM ProvisionalDZE · Abbreviated 12/16/2019SE
K191201EM SA Implant SystemDZE · Traditional 11/15/2019SE
K183242ET IV SA Dental ImplantsDZE · Special 05/21/2019SE
K180527IS3EKX · Traditional 05/16/2018SE

Questions and answers

When was Ek Multi Angled 30 Abutment cleared by the FDA?

Ek Multi Angled 30 Abutment (K251427) received a 510(k) decision of Substantially Equivalent on January 29, 2026, 266 days after the submission was received.

What is the product code of K251427?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.