Cleared Abbreviated

K093340 - PASR/QUIETNITE

K093340 is an FDA 510(k) clearance for PASR/QUIETNITE, manufactured by Exact Supplies , Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 228-day FDA review.

K093340 · Exact Supplies , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
228d
Days
Class 2
Risk

K093340 is an FDA 510(k) clearance for the PASR/QUIETNITE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Exact Supplies , Ltd. (Watlington, Oxfordshire, GB). The FDA issued a Cleared decision on June 11, 2010 after a review of 228 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K093340

510(k) Number K093340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2009
Decision Date June 11, 2010
Days to Decision 228 days
Submission Type Abbreviated
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
100d slower than avg
Panel avg: 128d · This submission: 228d
Pathway characteristics
Standards-based clearance path.

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 213
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K093340.
SNORE GUARD ADVANCE
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ZQUIET MOUTHPIECE
K093407 · Sleeping Well, LLC · Jun 2010
THE MOSES APPLIANCE
K093710 · Allen J. Moses, Dds, Ltd. · May 2010
AIRWAYEASE MAS
K090436 · Orthoplant Dental Lab · Apr 2010
VITAL SLEEP
K092942 · The Snore Reliever Company, LLC · Jan 2010
K093340 · PASR/QUIETNITE
Download PDF FDA Summary Exact Supplies , Ltd.