FDA 510(k) Application Details - K120784

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K120784
Device Name	Crown And Bridge, Temporary, Resin
Applicant	PULPDENT CORPORATION 80 Oakland St WATERTOWN, MA 02472 US Other 510(k) Applications for this Company
Contact	KENNETH J BERK Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2012
Decision Date	06/08/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review