FDA 510(k) Application Details - K133488

Device Classification Name	Drill, Bone, Powered   More FDA Info for this Device
510(K) Number	K133488
Device Name	Drill, Bone, Powered
Applicant	W & H DENTALWERK BUERMOOS GMBH IGNAZ-GLASER-STRASSE 53 BUERMOOS, SALZBURG 5111 AT Other 510(k) Applications for this Company
Contact	ANJA LINDNER Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2013
Decision Date	10/16/2014
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