FDA 510(k) Application Details - K133088

Device Classification Name	Anchor, Preformed   More FDA Info for this Device
510(K) Number	K133088
Device Name	Anchor, Preformed
Applicant	M&M DENTAL STUDIO INC 420 LEXINGTON AVE SUITE 2400 NEW YORK, NY 10170 US Other 510(k) Applications for this Company
Contact	IRVING WIESEN Other 510(k) Applications for this Contact
Regulation Number	872.3130   More FDA Info for this Regulation Number
Classification Product Code	EJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	01/02/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review