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510(k) K212563

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid by Prevest Denpro Limited — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2022
Date Received
August 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

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