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FDA 510(k) Application Details - K212563
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K212563
Device Name
Resin, Root Canal Filling
Applicant
Prevest Denpro Limited
Export Promotion Industrial Park
Bari Brahmana 181133 IN
Other 510(k) Applications for this Company
Contact
Atul Modi
Other 510(k) Applications for this Contact
Regulation Number
872.3820
More FDA Info for this Regulation Number
Classification Product Code
KIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2021
Decision Date
05/23/2022
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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