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510(k) K223798

Glidewell TuffSplint™ Appliance Resin by Prismatik Dentalcraft, Inc. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2023
Date Received
December 19, 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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