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FDA 510(k) Application Details - K100781
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K100781
Device Name
Powder, Porcelain
Applicant
PRISMATIK DENTALCRAFT, INC.
4141 MACARTHUR BLVD
NEWPORT BEACH, CA 92660 US
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Contact
KEITH ALLRED
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
03/19/2010
Decision Date
06/21/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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