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510(k) K130485

CONTROL SEAL by Voco GmbH — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2014
Date Received
February 25, 2013
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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