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FDA 510(k) Application Details - K211916
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K211916
Device Name
Powder, Porcelain
Applicant
Ivoclar Vivadent AG
Bendererstrasse 2
Schaan FL-9494 LI
Other 510(k) Applications for this Company
Contact
Sandra Cakebread
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
06/21/2021
Decision Date
08/20/2021
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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