Cleared Traditional

Oniris (K250353) - FDA 510(k) Clearance

Also marketed or referenced as:
Oniris Plus

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250353 · Oniris · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
209d
Days
Class 2
Risk

K250353 is an FDA 510(k) clearance for the Oniris. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Oniris (Rueil Malmaison, FR). The FDA issued a Cleared decision on September 4, 2025 after a review of 209 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Oniris devices

Submission Details

510(k) Number K250353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2025
Decision Date September 04, 2025
Days to Decision 209 days
Submission Type Traditional
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
82d slower than avg
Panel avg: 127d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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

Alizée Mareczko
Maria Markarova

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 - LRK Device, Anti-snoring

All 79
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K250353.
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