Cleared Abbreviated

K241003 - HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K241003 · Hiossen, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
271d
Days
Class 2
Risk

K241003 is an FDA 510(k) clearance for the HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment). Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on January 8, 2025 after a review of 271 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hiossen, Inc. devices

Submission Details

510(k) Number K241003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 127d · This submission: 271d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

IZiel Healthcare
Ankur Naik

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 701
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