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FDA 510(k) Application Details - K183304
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K183304
Device Name
Powder, Porcelain
Applicant
Zirkonzahn srl
Via An der Ahr 7
Gais 39030 IT
Other 510(k) Applications for this Company
Contact
Julian Steger
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
11/28/2018
Decision Date
04/04/2019
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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