Cleared Traditional

FILE-EZE (K934415) - FDA 510(k) Clearance

K934415 · Ultradent Products, Inc. · Dental device
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Apr 1994
Decision
215d
Days
-
Risk

K934415 is an FDA 510(k) clearance for the FILE-EZE. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Ultradent Products, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 13, 1994 after a review of 215 days - an extended review 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: 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 Ultradent Products, Inc. devices

Submission Details

510(k) Number K934415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1993
Decision Date April 13, 1994
Days to Decision 215 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
88d slower than avg
Panel avg: 127d · This submission: 215d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

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