K101245 is an FDA 510(k) clearance for the ULTRASEAL ID. 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 17, 2010, 136 days after receiving the submission on May 4, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K101245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2010 |
| Decision Date | September 17, 2010 |
| Days to Decision | 136 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 |