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FDA 510(k) Application Details - K093620
Device Classification Name
Varnish, Cavity
More FDA Info for this Device
510(K) Number
K093620
Device Name
Varnish, Cavity
Applicant
PULPDENT CORPORATION
80 OAKLAND ST.
P.O. BOX 780
WATERTOWN, MA 02471-0780 US
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Contact
KENNETH J BERK
Other 510(k) Applications for this Contact
Regulation Number
872.3260
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Classification Product Code
LBH
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More FDA Info for this Product Code
Date Received
11/23/2009
Decision Date
03/10/2010
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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