Cleared Traditional

EK MULTI ANGLED 30 ABUTMENT

K251427 · Hiossen, Inc. · Dental

Jan 2026

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K251427 is an FDA 510(k) clearance for the EK MULTI ANGLED 30 ABUTMENT, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Hiossen, Inc. (Fairless Hills, US). The FDA issued a Cleared decision on January 29, 2026, 266 days after receiving the submission on May 8, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K251427 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2025
Decision Date	January 29, 2026
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.