The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Endo-seal.
Device ID | K971899 |
510k Number | K971899 |
Device Name: | ENDO-SEAL |
Classification | Resin, Root Canal Filling |
Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
Contact | Chester Mccoy |
Correspondent | Chester Mccoy 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 | 1997-05-22 |
Decision Date | 1997-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDO-SEAL 75643264 not registered Dead/Abandoned |
WORLD MEDICAL MANUFACTURING CORPORATION 1999-02-18 |