The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultraseal Xt Hydro.
| Device ID | K112517 |
| 510k Number | K112517 |
| Device Name: | ULTRASEAL XT HYDRO |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Diane Rogers |
| Correspondent | Diane Rogers ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2011-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107442 | K112517 | 000 |
| 00883205104199 | K112517 | 000 |
| 00883205104182 | K112517 | 000 |
| 00883205104175 | K112517 | 000 |
| 00883205104168 | K112517 | 000 |
| 00883205104151 | K112517 | 000 |
| 00883205101310 | K112517 | 000 |
| 00883205019738 | K112517 | 000 |