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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 K203596
Device Name Panthera Occlusal Appliance
Applicant
Panthera Dental, Inc.
9105, Rue John-Simons
Quebec,  CA G2B 0S6
Applicant Contact Martine Fortin
Correspondent
Panthera Dental, Inc.
9105, Rue John-Simons
Quebec,  CA G2B 0S6
Correspondent Contact Martine Fortin
Classification Product Code
MQC  
Subsequent Product Code
OCO  
Date Received12/09/2020
Decision Date 04/20/2021
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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