FDA 510(k) Application Details - K080738

Device Classification Name	Unit, X-Ray, Intraoral   More FDA Info for this Device
510(K) Number	K080738
Device Name	Unit, X-Ray, Intraoral
Applicant	DENTRON SYSTEMS LLC 11 EAST GRANADA BLVD. SUITE 207 ORMOND BEACH, FL 32176 US Other 510(k) Applications for this Company
Contact	CLAUDE D BERTHOIN Other 510(k) Applications for this Contact
Regulation Number	872.1810   More FDA Info for this Regulation Number
Classification Product Code	EAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2008
Decision Date	05/13/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review