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FDA 510(k) Application Details - K191903
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K191903
Device Name
Powder, Porcelain
Applicant
Prismatik Dentalcraft, Inc.
2212 Dupont Dr.
Irvine, CA 92612 US
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Mythili Reguraman
Other 510(k) Applications for this Contact
Regulation Number
872.6660
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Classification Product Code
EIH
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More FDA Info for this Product Code
Date Received
07/16/2019
Decision Date
11/22/2019
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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