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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mouthguard, prescription
510(k) Number K212448
Device Name NightGuard Flex
Applicant
SprintRay Inc
2705 Media Center Drive, Suite 100A
Los Angeles,  CA  90065
Applicant Contact Sara Moghtadernejad
Correspondent
SprintRay Inc
2705 Media Center Drive, Suite 100A
Los Angeles,  CA  90065
Correspondent Contact Sara Moghtadernejad
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received08/05/2021
Decision Date 11/12/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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