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 |