FDA 510(k) Application Details - K000112

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K000112
Device Name	Unit, Operative Dental
Applicant	DENTSPLY INTL. 901 WEST OAKTON ST. DES PLAINES, IL 60018-1884 US Other 510(k) Applications for this Company
Contact	WILLIAM T COUSINS Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2000
Decision Date	04/13/2000
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