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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 K230548
Device Name Myoaligner Appliance
Applicant
Myohealth Technologies, LLC
13765 NW Cornell Rd Suite 150
Portland,  OR  97229
Applicant Contact Maryam Motlagh, DMD
Correspondent
The EyeDeas Company
21581 Midcrest Dr
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean, Ph.D.
Classification Product Code
MQC  
Subsequent Product Code
OCO  
Date Received02/28/2023
Decision Date 02/02/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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