FILE-EZE

Cleanser, Root Canal

ULTRADENT PRODUCTS, INC.

The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for File-eze.

Pre-market Notification Details

• Device ID: K060335
• 510k Number: K060335
• Device Name: FILE-EZE
• Classification: Cleanser, Root Canal
• Applicant: ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Contact: Tammy Lavery
• Correspondent: Tammy Lavery; ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095
• Product Code: KJJ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-02-09
• Decision Date: 2006-02-24
• Summary: summary