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FDA 510(k) Application Details - K020287
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
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510(K) Number
K020287
Device Name
Sealant, Pit And Fissure, And Conditioner
Applicant
PULPDENT CORPORATION
80 OAKLAND ST.
WATERTOWN, MA 02472 US
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Contact
KENNETH J BERK
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Regulation Number
872.3765
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Classification Product Code
EBC
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More FDA Info for this Product Code
Date Received
01/28/2002
Decision Date
04/12/2002
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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