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510(k) K220894

SmileGuard by Envisiontec GmbH — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2022
Date Received
March 28, 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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