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FDA 510(k) Application Details - K052515
Device Classification Name
Handpiece, Direct Drive, Ac-Powered
More FDA Info for this Device
510(K) Number
K052515
Device Name
Handpiece, Direct Drive, Ac-Powered
Applicant
SIRONA DENTAL SYSTEMS GMBH
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760-4153 US
Other 510(k) Applications for this Company
Contact
MARY MCNAMARA-CULLINANE
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2005
Decision Date
03/31/2006
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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