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FDA 510(k) Application Details - K031932
Device Classification Name
Varnish, Cavity
More FDA Info for this Device
510(K) Number
K031932
Device Name
Varnish, Cavity
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK, PA 17405 US
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Contact
P. JEFFERY LEHN
Other 510(k) Applications for this Contact
Regulation Number
872.3260
More FDA Info for this Regulation Number
Classification Product Code
LBH
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More FDA Info for this Product Code
Date Received
06/23/2003
Decision Date
09/15/2003
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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