Cleared Traditional

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

K934415 · Ultradent Products, Inc. · Dental device

Apr 1994

Decision

215d

Days

—

Risk

K934415 is an FDA 510(k) clearance for the FILE-EZE. This device is classified as a Cleanser, Root Canal.

Submitted by Ultradent Products, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 13, 1994, 215 days after receiving the submission on September 10, 1993.

This device falls under the Dental FDA review panel.

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

Device Classification

Product Code	KJJ — Cleanser, Root Canal
Device Class	—