FDA 510(k) Application Details - K203596

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K203596
Device Name	Mouthguard, Prescription
Applicant	Panthera Dental Inc. 9105, rue John-Simons Quebec G2B 0S6 CA Other 510(k) Applications for this Company
Contact	Martine Fortin Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2020
Decision Date	04/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review