The following data is part of a premarket notification filed by Ita.o Italian Orthodontic System S.r.l. with the FDA for Orthodontic Facemask.
| Device ID | K202855 |
| 510k Number | K202855 |
| Device Name: | Orthodontic Facemask |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | ITA.O Italian Orthodontic System S.r.l. Via Merighi, 30/3 - 30/4 Villanova Di Castenaso, IT 40055 |
| Contact | Alessandra Ferroni |
| Correspondent | Marisa Testa Thema SRL Via Saragat, 5 Imola, IT 40026 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052675320091 | K202855 | 000 |
| 08052675320015 | K202855 | 000 |
| 08052675320022 | K202855 | 000 |
| 08052675320039 | K202855 | 000 |
| 08052675320046 | K202855 | 000 |
| 08052675320053 | K202855 | 000 |
| 08052675320060 | K202855 | 000 |
| 08052675320077 | K202855 | 000 |
| 08052675320084 | K202855 | 000 |
| 08052675320008 | K202855 | 000 |