K210945 is an FDA 510(k) clearance for the Ultra SEP. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on July 8, 2021, 100 days after receiving the submission on March 30, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K210945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2021 |
| Decision Date | July 08, 2021 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |