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FDA 510(k) Application Details - K014238
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K014238
Device Name
Scaler, Ultrasonic
Applicant
DELDENT LTD.
19 KEREN KAYEMET ST.
PETACH TIKVAH 49372 IL
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Contact
ALAN EDEL
Other 510(k) Applications for this Contact
Regulation Number
872.4850
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Classification Product Code
ELC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2001
Decision Date
01/24/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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