Cleared Traditional

T-GUARD (K945537) - FDA 510(k) Clearance

Class I Dental device.

K945537 · Med ET AL Development · Dental device
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Mar 1995
Decision
129d
Days
Class 1
Risk

K945537 is an FDA 510(k) clearance for the T-GUARD. Classified as Device, Finger-sucking (product code LQX), Class I - General Controls.

Submitted by Med ET AL Development (Matthews, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.3475 - 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 Med ET AL Development devices

Submission Details

510(k) Number K945537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date March 23, 1995
Days to Decision 129 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
2d slower than avg
Panel avg: 127d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQX Device, Finger-sucking
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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.