Cleared Traditional

K946112 - ELASTOMERIC SLEEP APPLIANCE

K946112 is an FDA 510(k) clearance for ELASTOMERIC SLEEP APPLIANCE, manufactured by Village Park Orthodontics. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K946112 · Village Park Orthodontics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
181d
Days
Class 2
Risk

K946112 is an FDA 510(k) clearance for the ELASTOMERIC SLEEP APPLIANCE. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Village Park Orthodontics (Depew, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 181 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 Village Park Orthodontics devices

FDA 510(k) Submission Details - K946112

510(k) Number K946112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1994
Decision Date June 14, 1995
Days to Decision 181 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
54d slower than avg
Panel avg: 127d · This submission: 181d
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.