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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205105875 | K060335 | 000 |
| 00883205103956 | K060335 | 000 |
| 00883205103468 | K060335 | 000 |
| 00883205019356 | K060335 | 000 |
Trademark Results [FILE-EZE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FILE-EZE 74237678 1714978 Live/Registered |
Ultradent Products, Inc. 1992-01-14 |
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