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FDA 510(k) Application Details - K130924
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K130924
Device Name
Powder, Porcelain
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR.,
SUITE JJK
IRVINE, CA 92612 US
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Contact
ARMIN ZEHTABCHI
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
04/03/2013
Decision Date
05/16/2013
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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