Cleared Traditional

K931352 - PEDO JACKETS OR PJ'S

K931352 is an FDA 510(k) clearance for PEDO JACKETS OR PJ'S, manufactured by George M. Wilson, Dds. The device is a Class 1 Dental device with product code ELZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K931352 · George M. Wilson, Dds · Dental device
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Jul 1993
Decision
126d
Days
Class 1
Risk

K931352 is an FDA 510(k) clearance for the PEDO JACKETS OR PJ'S. Classified as Crown, Preformed (product code ELZ), Class I - General Controls.

Submitted by George M. Wilson, Dds (Porterville, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3330 - 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 George M. Wilson, Dds devices

FDA 510(k) Submission Details - K931352

510(k) Number K931352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date July 21, 1993
Days to Decision 126 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
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

ELZ Device Classification - Class 1, General Controls

Product Code ELZ Crown, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3330
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.