Cleared Traditional

K932511 - SILICONE MIRROR (FDA 510(k) Clearance)

Class I Dental device.

K932511 · Moyco Industries, Inc. · Dental device
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Nov 1993
Decision
164d
Days
Class 1
Risk

K932511 is an FDA 510(k) clearance for the SILICONE MIRROR. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Moyco Industries, Inc. (Philadelphia, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 164 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Moyco Industries, Inc. devices

Submission Details

510(k) Number K932511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date November 05, 1993
Days to Decision 164 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
37d slower than avg
Panel avg: 127d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.