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FDA 510(k) Application Details - K180185
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K180185
Device Name
Resin, Root Canal Filling
Applicant
Angelus Industria de Produtos Odontologicos S/A
Rua Waldir Landgraf, 101
Londrina 86.031-218 BR
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Contact
Paulo Sergio Calixto de Oliveria
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Regulation Number
872.3820
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Classification Product Code
KIF
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More FDA Info for this Product Code
Date Received
01/23/2018
Decision Date
08/31/2018
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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