Cleared Traditional

SNOREMASTER SNORE REMEDY (K932932) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932932 · The Snoremaster Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
604d
Days
Class 2
Risk

K932932 is an FDA 510(k) clearance for the SNOREMASTER SNORE REMEDY. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by The Snoremaster Co. (Philadelphia, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 604 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all The Snoremaster Co. devices

Submission Details

510(k) Number K932932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1993
Decision Date February 10, 1995
Days to Decision 604 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
477d slower than avg
Panel avg: 127d · This submission: 604d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQZ Device, Jaw Repositioning
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.