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510(k) K212767

SleepRight Select-Comfort Dental Guard by Splintek, Inc. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2021
Date Received
August 31, 2021
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

Other clearances by Splintek, Inc.

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