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FDA 510(k) Application Details - K052334
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K052334
Device Name
Scaler, Ultrasonic
Applicant
DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
YORK, PA 17404 US
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Contact
HELEN LEWIS
Other 510(k) Applications for this Contact
Regulation Number
872.4850
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Classification Product Code
ELC
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More FDA Info for this Product Code
Date Received
08/26/2005
Decision Date
09/02/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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