FDA 510(k) Application Details - K212706

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K212706
Device Name	Mouthguard, Over-The-Counter
Applicant	Splintek, Inc. 15555 West 108th Street Lenexa, KS 66219 US Other 510(k) Applications for this Company
Contact	Thomas W. Brown Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2021
Decision Date	12/13/2021
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