Cleared Traditional

K132506 - SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY

K132506 is an FDA 510(k) clearance for SLEEPTIGHT MOUTHPIECE, manufactured by Michael D Williams Dds PA. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K132506 · Michael D Williams Dds PA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
290d
Days
Class 2
Risk

K132506 is an FDA 510(k) clearance for the SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Michael D Williams Dds PA (Davie, US). The FDA issued a Cleared decision on May 29, 2014 after a review of 290 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 Michael D Williams Dds PA devices

FDA 510(k) Submission Details - K132506

510(k) Number K132506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2013
Decision Date May 29, 2014
Days to Decision 290 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
163d slower than avg
Panel avg: 127d · This submission: 290d
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 167
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K132506.
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K140278 · Somnomed, Inc. · Jun 2014
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LUCO HYBRID OSA APPLIANCE
K130797 · Luco Hybrid Osa Appliance, Inc. · Dec 2013