FDA 510(k) Application Details - K222604

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K222604
Device Name	Mouthguard, Prescription
Applicant	dentona AG Otto-Hahn-Strasse 27 Dortmund 44227 DE Other 510(k) Applications for this Company
Contact	Andreas Foerster 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	08/29/2022
Decision Date	04/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review