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FDA 510(k) Application Details - K230262
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K230262
Device Name
Powder, Porcelain
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine, CA 92612 US
Other 510(k) Applications for this Company
Contact
So Hyun Park
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
01/31/2023
Decision Date
05/16/2023
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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