Cleared Traditional

K090503 - ZQUIET MOUTHPIECE

K090503 is an FDA 510(k) clearance for ZQUIET MOUTHPIECE, manufactured by Sleeping Well, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K090503 · Sleeping Well, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
13d
Days
Class 2
Risk

K090503 is an FDA 510(k) clearance for the ZQUIET MOUTHPIECE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Sleeping Well, LLC (Crofton, US). The FDA issued a Cleared decision on March 10, 2009 after a review of 13 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sleeping Well, LLC devices

FDA 510(k) Submission Details - K090503

510(k) Number K090503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date March 10, 2009
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.

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 205
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K090503.
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MPOWRX SNORING SOLUTION
K081965 · Mpowrx Health and Wellness Products, Inc. · Oct 2008
ENDSNOR
K072731 · Dockstader Orthodontic Lab, Inc. · Jun 2008