Cleared Abbreviated

K182202 - SLEEPAPP

K182202 is the FDA 510(k) clearance for SLEEPAPP by Comfort Acrylics, Inc.. It is a Class 2 Dental device (product code LRK) cleared through the Abbreviated 510(k) pathway after a 150-day FDA review.

K182202 · Comfort Acrylics, Inc. · Dental device
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Jan 2019
Decision
150d
Days
Class 2
Risk

K182202 is an FDA 510(k) clearance for the SLEEPAPP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Comfort Acrylics, Inc. (Camas, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 150 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.

View all Comfort Acrylics, Inc. devices

Submission Details

510(k) Number K182202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2018
Decision Date January 11, 2019
Days to Decision 150 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 127d · This submission: 150d
Pathway characteristics
Standards-based clearance path.

Device Classification

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

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