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510(k) K222604

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S by Dentona AG — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2023
Date Received
August 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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