Cleared Traditional

K140777 - ZQUIET-SA

K140777 is an FDA 510(k) clearance for ZQUIET-SA, 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 119-day FDA review.

K140777 · Sleeping Well, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
119d
Days
Class 2
Risk

K140777 is an FDA 510(k) clearance for the ZQUIET-SA. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Sleeping Well, LLC (Leola, US). The FDA issued a Cleared decision on July 25, 2014 after a review of 119 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 Sleeping Well, LLC devices

FDA 510(k) Submission Details - K140777

510(k) Number K140777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2014
Decision Date July 25, 2014
Days to Decision 119 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
9d faster than avg
Panel avg: 128d · This submission: 119d
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 205
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K140777.
THERASNORE
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MEDLEY GOLD
K140435 · American Dental Sleep Medicine, Ip, LLC · Jun 2014
SOMNODENT FUSION, CLASSIC
K140278 · Somnomed, Inc. · Jun 2014