Cleared Traditional

K934415 - FILE-EZE

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

FDA 510(k) Submission Details - K934415

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 127d · This submission: 215d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -