Cleared Traditional

Fibercure

K232076 · Lumendo AG · Dental
Nov 2023
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K232076 is an FDA 510(k) clearance for the Fibercure, a Laser Activator For Polymerization (Class II — Special Controls, product code QNF), submitted by Lumendo AG (Renens, CH). The FDA issued a Cleared decision on November 2, 2023, 112 days after receiving the submission on July 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K232076 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2023
Decision Date November 02, 2023
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code QNF — Laser Activator For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070
Definition Intended To Polymerize Dental Restorative Resins