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FDA 510(k) Application Details - K050354
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K050354
Device Name
Scaler, Ultrasonic
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
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/14/2005
Decision Date
03/21/2005
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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