Cleared Traditional

MOYCO-EDTA (K950365) - FDA 510(k) Clearance

K950365 · Union Broach, Div. Moyco Industries, Inc. · Dental device
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Apr 1995
Decision
86d
Days
-
Risk

K950365 is an FDA 510(k) clearance for the MOYCO-EDTA. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Union Broach, Div. Moyco Industries, Inc. (Emigsville, US). The FDA issued a Cleared decision on April 27, 1995 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Union Broach, Div. Moyco Industries, Inc. devices

Submission Details

510(k) Number K950365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date April 27, 1995
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -