K112517 is an FDA 510(k) clearance for the ULTRASEAL XT HYDRO. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 23, 2011, 23 days after receiving the submission on August 31, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K112517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2011 |
| Decision Date | September 23, 2011 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |