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510(k) K202855

Orthodontic Facemask by Ita.O Italian Orthodontic System S.R.L. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2021
Date Received
September 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

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  • K993224 — T-GEAR, MODEL TG/400-700 (February 11, 2000)
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