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FDA 510(k) Application Details - K150535
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K150535
Device Name
Scaler, Ultrasonic
Applicant
DENTSPLY INTERNATIONAL, INC.
221 WEST PHILADELPHIA ST.
SUITE 60W
YORK, PA 17401 US
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Contact
HELEN LEWIS
Other 510(k) Applications for this Contact
Regulation Number
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
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More FDA Info for this Product Code
Date Received
03/03/2015
Decision Date
06/16/2015
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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