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510(k) K060889

SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE by Pentron Clinical Technologies — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2006
Date Received
March 31, 2006
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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