Cleared Traditional

K112627 - MILLENIUM ANTI-SNORING DEVICE

K112627 is an FDA 510(k) clearance for MILLENIUM ANTI-SNORING DEVICE, manufactured by Millenium Dental Laboratory, Inc.. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K112627 · Millenium Dental Laboratory, Inc. · Dental device
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Jun 2012
Decision
271d
Days
Class 2
Risk

K112627 is an FDA 510(k) clearance for the MILLENIUM ANTI-SNORING DEVICE. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Millenium Dental Laboratory, Inc. (Ramsey, US). The FDA issued a Cleared decision on June 6, 2012 after a review of 271 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 Millenium Dental Laboratory, Inc. devices

FDA 510(k) Submission Details - K112627

510(k) Number K112627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2011
Decision Date June 06, 2012
Days to Decision 271 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 127d · This submission: 271d
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.