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510(k) K140132

BIODENTINE by Septodont — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2014
Date Received
January 17, 2014
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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