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510(k) K063856

EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM by Essential Dental Systems, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2007
Date Received
December 28, 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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