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510(k) K231263

Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT by Prevest Denpro Limited — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2024
Date Received
May 2, 2023
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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