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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K233434
Device Name Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Applicant Contact Jiahe Li
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Correspondent Contact Jiahe Li
Regulation Number872.5570
Classification Product Code
LRK  
Date Received10/13/2023
Decision Date 11/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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