K202855 is an FDA 510(k) clearance for the Orthodontic Facemask. This device is classified as a Headgear, Extraoral, Orthodontic (Class II - Special Controls, product code DZB).
Submitted by Ita.O Italian Orthodontic System S.R.L. (Villanova Di Castenaso, IT). The FDA issued a Cleared decision on June 21, 2021, 266 days after receiving the submission on September 28, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.
| 510(k) Number | K202855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2020 |
| Decision Date | June 21, 2021 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZB - Headgear, Extraoral, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5500 |