FDA 510(k) Application Details - K151646

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K151646
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	PROTECH PROFESSIONAL PRODUCTS, INC. 2900 N.W. COMMERCE PARK DRIVE, STE 10 BOYNTON BEACH, FL 33426 US Other 510(k) Applications for this Company
Contact	ADAM BLOCH Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2015
Decision Date	10/21/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review