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510(k) K052281

EMBRACE WETBOND CLEAR SEALANT by Pulpdent Corporation — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2006
Date Received
August 22, 2005
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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