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510(k) K111782

BEAUTISEALANT by Shofu Dental Corporation — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2011
Date Received
June 24, 2011
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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