ENDOREZ
Resin, Root Canal Filling
ULTRADENT PRODUCTS, INC.
The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Endorez.
Pre-market Notification Details
| Device ID | K042756 |
| 510k Number | K042756 |
| Device Name: | ENDOREZ |
| Classification | Resin, Root Canal Filling |
| 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 | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2004-10-26 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107848 | K042756 | 000 |
| 00883205107831 | K042756 | 000 |
| 00883205107824 | K042756 | 000 |
| 00883205106803 | K042756 | 000 |
| 00883205102768 | K042756 | 000 |
Trademark Results [ENDOREZ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOREZ 75874379 2505423 Live/Registered |
Ultradent Products, Inc. 1999-12-17 |
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