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FDA 510(k) Application Details - K070538
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K070538
Device Name
Agent, Tooth Bonding, Resin
Applicant
DENTSPLY INTL.
221 WEST PHILADELPHIA STREET
SUITE 60
YORK, PA 17404 US
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Contact
HELEN LEWIS
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Regulation Number
872.3200
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Classification Product Code
KLE
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More FDA Info for this Product Code
Date Received
02/26/2007
Decision Date
03/14/2007
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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