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510(k) K071158

AURALAY PIT & FISSURE SEALANT by Denali Corporation — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2007
Date Received
April 25, 2007
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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  • K070702 — FUSION RESIN CEMENT AND CORE KIT (May 10, 2007)
  • K070693 — AURAVUE PIT & FISSURE SEALANT (May 9, 2007)

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