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510(k) K070702

FUSION RESIN CEMENT AND CORE KIT by Denali Corporation — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2007
Date Received
March 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K070693 — AURAVUE PIT & FISSURE SEALANT (May 9, 2007)

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