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FDA 510(k) Application Details - K123615
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K123615
Device Name
Powder, Porcelain
Applicant
DENTSPLY INTL.
21 W PHILADEPHIA STREET
SUITE 60W
YORK, PA 17405 US
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Contact
HELEN LEWIS
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2012
Decision Date
02/22/2013
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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