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FDA 510(k) Application Details - K202281
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K202281
Device Name
Resin, Root Canal Filling
Applicant
Essential Dental Systems
89 Leuning Street
South Hackensack, NJ 07606 US
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Contact
Jason Guzman
Other 510(k) Applications for this Contact
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
08/12/2020
Decision Date
02/12/2021
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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