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FDA 510(k) Application Details - K131319
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K131319
Device Name
Handpiece, Air-Powered, Dental
Applicant
SIRONA DENTAL SYSTEMS GMBH
FABRIKSTRASSE 31
BENSHEIM D-64625 DE
Other 510(k) Applications for this Company
Contact
FRITZ KOLLE
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/07/2013
Decision Date
05/30/2014
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
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