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510(k) K123538

EPIEN ROOT CANAL CLEANSER by Epien Medical, Inc. — Product Code KJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2013
Date Received
November 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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