Cleared Traditional

K251628 - Mandibular Advancement Device L07

K251628 is an FDA 510(k) clearance for Mandibular Advancement Device L07, manufactured by Dcstar, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K251628 · Dcstar, Inc. · Dental device
Download Printable Device Report (PDF)
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Oct 2025
Decision
147d
Days
Class 2
Risk

K251628 is an FDA 510(k) clearance for the Mandibular Advancement Device L07. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Dcstar, Inc. (New York, US). The FDA issued a Cleared decision on October 22, 2025 after a review of 147 days - within the typical 510(k) review window.

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 Dcstar, Inc. devices

FDA 510(k) Submission Details - K251628

510(k) Number K251628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2025
Decision Date October 22, 2025
Days to Decision 147 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
20d slower than avg
Panel avg: 127d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

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 85
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