FDA 510(k) Application Details - K092851

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K092851
Device Name	Unit, Operative Dental
Applicant	GLOBAL DENTAL DIRECT, INC. 2120 PARAMOUNT CRESCENT SUITE 4 ABBOTSFORD, BC V2T-6A5 CA Other 510(k) Applications for this Company
Contact	DON TEMPLE 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	09/16/2009
Decision Date	09/29/2009
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	Y
Expedited Review