Cleared Traditional

K963063 - SNORE TEC

K963063 is an FDA 510(k) clearance for SNORE TEC, manufactured by Marketing Technologies, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K963063 · Marketing Technologies, Inc. · Dental device
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Apr 1997
Decision
250d
Days
Class 2
Risk

K963063 is an FDA 510(k) clearance for the SNORE TEC. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Marketing Technologies, Inc. (Bakersfield, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 250 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 Marketing Technologies, Inc. devices

FDA 510(k) Submission Details - K963063

510(k) Number K963063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date April 14, 1997
Days to Decision 250 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
123d slower than avg
Panel avg: 127d · This submission: 250d
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 K963063.
SILENTNITE
K972424 · Glidewell Laboratories · Sep 1997
SLEEP-IN BONE SCREW SYSTEM
K972023 · Influence, Inc. · Aug 1997
TOA
K972061 · W. Keith Thornton, D.D.S. · Aug 1997
TAP
K964516 · Nellcor Puritan Bennett, Inc. · Jan 1997
TAP ANTI-SNORING DEVICE
K962516 · Nellcor Puritan Bennett, Inc. · Sep 1996
REMOVABLE HERBST APPLIANCE
K955822 · Univ. Dental Assoc. Department of Orthodontics · Mar 1996