K-number	K202855
Device name	Orthodontic Facemask
Applicant	Ita.O Italian Orthodontic System S.R.L.
Product code	DZB
Device class	Class II
Decision date	Jun 21, 2021
Decision	Substantially Equivalent
Regulation	872.5500

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Source

View the full FDA submission: accessdata.fda.gov

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Orthodontic Facemask

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