FDA 510(k) Application Details - K210011

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K210011
Device Name	Mouthguard, Prescription
Applicant	Ampower Dental Laboratories, LLC 3423 Investment Blvd Suite 11 Hayward Hayward, CA 94545 US Other 510(k) Applications for this Company
Contact	Dylan Hao 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	01/04/2021
Decision Date	07/16/2021
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