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510(k) K233434

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) by Prismatik Dentalcraft, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2023
Date Received
October 13, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

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