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510(k) K141717

PACSEAL PIT & FISSURE SEALANT by Pac-Dent International, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2015
Date Received
June 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

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