FDA 510(k)

FILE-EZE

K-Number: K060335 · 2006-02-24

Decision Date2006-02-24

Product CodeKJJ

DecisionSubstantially Equivalent

Device Summary

FILE-EZE is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2006-02-24 under 510(k) number K060335. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILE-EZE?

FILE-EZE is a medical device that received FDA 510(k) clearance on 2006-02-24. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K060335.

When did FILE-EZE receive FDA 510(k) clearance?

FILE-EZE received FDA 510(k) clearance on 2006-02-24, under 510(k) number K060335.

Who is the listed applicant for FILE-EZE?

The FDA 510(k) record lists Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILE-EZE?

The FDA product code for FILE-EZE is KJJ.

Other records listing Ultradent Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.