Cleared Abbreviated

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

K241003 · Hiossen, Inc. · Dental

Jan 2025

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K241003 is an FDA 510(k) clearance for the HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment), a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on January 8, 2025, 271 days after receiving the submission on April 12, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K241003 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2024
Decision Date	January 08, 2025
Days to Decision	271 days
Submission Type	Abbreviated
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.