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510(k) K061997

PREMIER SELF-ETCHING ENAMEL SEALANT by Premier Dental Products Co. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2006
Date Received
July 14, 2006
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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