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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 K222845
Device Name Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
Applicant
Frey Oral Technologies, LLC
433 N. Camden Dr., Suite 1070
Beverly Hills,  CA  90210
Applicant Contact David Frey
Correspondent
Frey Oral Technologies, LLC
433 N. Camden Dr., Suite 1070
Beverly Hills,  CA  90210
Correspondent Contact David Frey
Classification Product Code
MQC  
Subsequent Product Code
OCO  
Date Received09/21/2022
Decision Date 11/28/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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