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FDA 510(k) Application Details - K180562
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K180562
Device Name
Crown And Bridge, Temporary, Resin
Applicant
Zirkonzahn Gmbh
Gewerbegebiet - Zona Industriale An der Ahr 7
Gais 39030 IT
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Contact
Julian Steger
Other 510(k) Applications for this Contact
Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/05/2018
Decision Date
06/28/2018
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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