Cleared Traditional

K093407 - ZQUIET MOUTHPIECE

K093407 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 232-day FDA review.

K093407 · Sleeping Well, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
232d
Days
Class 2
Risk

K093407 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 June 22, 2010 after a review of 232 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 Sleeping Well, LLC devices

FDA 510(k) Submission Details - K093407

510(k) Number K093407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2009
Decision Date June 22, 2010
Days to Decision 232 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 127d · This submission: 232d
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 86
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K093407.
Snorer's Friend
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K110623 · Medtronic Xomed, Inc. · Feb 2012
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K070327 · Sybron Dental Specialties, Inc. · May 2007
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004