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510(k) K232076

Fibercure by Lumendo AG — Product Code QNF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 2, 2023
Date Received: July 13, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laser Activator For Polymerization
Device Class: Class II
Regulation Number: 872.6070
Review Panel: DE
Submission Type

Intended to polymerize dental restorative resins