Cleared Traditional

K880956 - SNOAR(TM) OPEN AIRWAY APPLIANCE

K880956 is an FDA 510(k) clearance for SNOAR(TM) OPEN AIRWAY APPLIANCE, manufactured by Kent J. Toone, D.D.S.. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K880956 · Kent J. Toone, D.D.S. · Dental device
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May 1988
Decision
65d
Days
Class 2
Risk

K880956 is an FDA 510(k) clearance for the SNOAR(TM) OPEN AIRWAY APPLIANCE. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Kent J. Toone, D.D.S. (Cupertino, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 65 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 Kent J. Toone, D.D.S. devices

FDA 510(k) Submission Details - K880956

510(k) Number K880956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date May 11, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQZ Device Classification - Class 2, Special Controls

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.