Cleared Traditional

K972424 - SILENTNITE

K972424 is an FDA 510(k) clearance for SILENTNITE, manufactured by Glidewell Laboratories. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K972424 · Glidewell Laboratories · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
83d
Days
Class 2
Risk

K972424 is an FDA 510(k) clearance for the SILENTNITE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Glidewell Laboratories (Newport Beach, US). The FDA issued a Cleared decision on September 18, 1997 after a review of 83 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 Glidewell Laboratories devices

FDA 510(k) Submission Details - K972424

510(k) Number K972424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1997
Decision Date September 18, 1997
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 113
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K972424.
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
K973884 · Frantz Design, Inc. · Jan 1998
ADJUSTABLE THERASNORE
K973038 · Distar, Inc. · Nov 1997
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
K971794 · Frantz Design, Inc. · Sep 1997
SLEEP-IN BONE SCREW SYSTEM
K972023 · Influence, Inc. · Aug 1997
TOA
K972061 · W. Keith Thornton, D.D.S. · Aug 1997
SNORE TEC
K963063 · Marketing Technologies, Inc. · Apr 1997