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510(k) Data Aggregation

K Number

Device Name

Orthodontic Facemask

Manufacturer

ITA.O Italian Orthodontic System S.r.l.

Date Cleared

2021-06-21

(266 days)

Product Code

DZB

Regulation Number

872.5500

Why did this record match?

Applicant Name (Manufacturer) :

ITA.O Italian Orthodontic System S.r.l.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Orthodontic Facemask is used as a treatment option for Class III malocclusions.

Device Description

Not Found

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