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 |