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 |