Cleared Traditional

Anti Snore Mouthpiece (K250028) - FDA 510(k) Clearance

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

K250028 · Dongguan Yiyao Science & Technology Development Co., Ltd. · Dental device
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Oct 2025
Decision
270d
Days
Class 2
Risk

K250028 is an FDA 510(k) clearance for the Anti Snore Mouthpiece. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Dongguan Yiyao Science & Technology Development Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on October 3, 2025 after a review of 270 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 Dongguan Yiyao Science & Technology Development Co., Ltd. devices

Submission Details

510(k) Number K250028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2025
Decision Date October 03, 2025
Days to Decision 270 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
143d slower than avg
Panel avg: 127d · This submission: 270d
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 Peers - LRK Device, Anti-snoring

All 79
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