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510(k) K161580

Premier Sealant by Premier Dental Company Products — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2016
Date Received
June 8, 2016
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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