The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultradent Product Dentin Condition & Seal Prod Lin.
| Device ID | K921599 |
| 510k Number | K921599 |
| Device Name: | ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Linda Chatwin |
| Correspondent | Linda Chatwin ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-03 |
| Decision Date | 1992-09-28 |