The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Endorez.
| Device ID | K992097 |
| 510k Number | K992097 |
| Device Name: | ENDOREZ |
| Classification | Resin, Root Canal Filling |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Scott E Moore |
| Correspondent | Scott E Moore ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-21 |
| Decision Date | 1999-10-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOREZ 75874379 2505423 Live/Registered |
Ultradent Products, Inc. 1999-12-17 |