FDA 510(k) Application Details - K964430

Device Classification Name	Device, Caries Detection   More FDA Info for this Device
510(K) Number	K964430
Device Name	Device, Caries Detection
Applicant	PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 WATERTOWN, MA 02471-0780 US Other 510(k) Applications for this Company
Contact	KENNETH J BERK Other 510(k) Applications for this Contact
Regulation Number	872.1740   More FDA Info for this Regulation Number
Classification Product Code	LFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/1996
Decision Date	01/17/1997
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