FDA 510(k) Application Details - K083400

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K083400
Device Name	Mouthguard, Over-The-Counter
Applicant	DENTEK ORAL CARE, INC. 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN 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	11/17/2008
Decision Date	12/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review