Cleared Traditional

THE TMJ APPLIANCE (K924974) - FDA 510(k) Clearance

Class I Dental device.

K924974 · Myofunctional Research Corp. Pty. , Ltd. · Dental device
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Jun 1993
Decision
266d
Days
Class 1
Risk

K924974 is an FDA 510(k) clearance for the THE TMJ APPLIANCE. Classified as Positioner, Tooth, Preformed (product code KMY), Class I - General Controls.

Submitted by Myofunctional Research Corp. Pty. , Ltd. (Helensvale, Queensland, AU). The FDA issued a Cleared decision on June 23, 1993 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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 Myofunctional Research Corp. Pty. , Ltd. devices

Submission Details

510(k) Number K924974 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 30, 1992
Decision Date June 23, 1993
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMY Positioner, Tooth, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.