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510(k) K153191

Calcium Bridge by Denali Corporation — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2016
Date Received
November 3, 2015
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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  • K070702 — FUSION RESIN CEMENT AND CORE KIT (May 10, 2007)
  • K070693 — AURAVUE PIT & FISSURE SEALANT (May 9, 2007)

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