FDA 510(k) Application Details - K211415

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K211415
Device Name	Mouthguard, Prescription
Applicant	Pro3dure Medical GmbH Am Burgberg 13 Iserlohn 58642 DE Other 510(k) Applications for this Company
Contact	Frank Gischer 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	05/06/2021
Decision Date	10/21/2021
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