FDA 510(k) Application Details - K982105

Device Classification Name	Device, Caries Detection   More FDA Info for this Device
510(K) Number	K982105
Device Name	Device, Caries Detection
Applicant	PERTEC OF WISCONSIN, INC. 10971 CLINIC RD. SURING, WI 54174 US Other 510(k) Applications for this Company
Contact	DOUGLAS L COOK 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	06/16/1998
Decision Date	09/16/1998
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