Cleared Traditional

K974531 - SNORE-EZZER

K974531 is an FDA 510(k) clearance for SNORE-EZZER, manufactured by Snore - Ezzer. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K974531 · Snore - Ezzer · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
72d
Days
Class 2
Risk

K974531 is an FDA 510(k) clearance for the SNORE-EZZER. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Snore - Ezzer (Waukesha, US). The FDA issued a Cleared decision on February 12, 1998 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Snore - Ezzer devices

FDA 510(k) Submission Details - K974531

510(k) Number K974531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1997
Decision Date February 12, 1998
Days to Decision 72 days
Submission Type Traditional
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
55d faster than avg
Panel avg: 127d · This submission: 72d
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 112
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K974531.
SNORE-AID PLUS
K991449 · Dental Imagineers, LLC · Jul 1999
THE SNORE PEACE
K981923 · The Snore Peace Group · Aug 1998
SNORE-CURE ANTI-SNORING APPLIANCE
K980952 · Ortho-Tain, Inc. · Jun 1998
SNORING CONTROL DEVICE
K963591 · Kenneth Hilsen · Jan 1998
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
K973884 · Frantz Design, Inc. · Jan 1998
ADJUSTABLE THERASNORE
K973038 · Distar, Inc. · Nov 1997