Orthodontic Facemask
K-Number: K202855 · 2021-06-21
Decision Date2021-06-21
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Orthodontic Facemask is a medical device manufactured by Ita.O Italian Orthodontic System S.R.L.. It received FDA 510(k) clearance on 2021-06-21 under approval number K202855. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Orthodontic Facemask?
Orthodontic Facemask is a medical device that received FDA 510(k) clearance on 2021-06-21. It is manufactured by Ita.O Italian Orthodontic System S.R.L.. The 510(k) number is K202855.
When was Orthodontic Facemask approved by the FDA?
Orthodontic Facemask received FDA 510(k) clearance on 2021-06-21, under approval number K202855.
What company makes Orthodontic Facemask?
Orthodontic Facemask is manufactured by Ita.O Italian Orthodontic System S.R.L..
What is the FDA product code for Orthodontic Facemask?
The FDA product code for Orthodontic Facemask is DZB.
Related Devices (Code: DZB)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.