FDA 510(k) Application Details - K133178

Device Classification Name	Handpiece, Contra- And Right-Angle Attachment, Dental   More FDA Info for this Device
510(K) Number	K133178
Device Name	Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant	DIRECTA AB P.O. BOX 723 UPPLANDS VASBY SE-194 47 SE Other 510(k) Applications for this Company
Contact	HENRIC KARSK Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2013
Decision Date	11/24/2015
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