FDA 510(k) Application Details - K183315

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K183315
Device Name	Mouthguard, Over-The-Counter
Applicant	Dental Choice Holdings, LLC 10100 Linn Station Road Louisville, KY 40223 US Other 510(k) Applications for this Company
Contact	Ron Story 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	11/30/2018
Decision Date	08/23/2019
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