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510(k) K101540

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE by Novocol Inc. Dba Septodont and Confi-Dental Produc — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2010
Date Received
June 3, 2010
Clearance Type
Abbreviated
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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