510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232076Substantially Equivalent

Fibercure

Lumendo AG, Renens, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232076 is the FDA 510(k) clearance record for Fibercure, a class II device, cleared for Lumendo AG on under FDA product code QNF (Laser Activator For Polymerization). FDA's definition for product code QNF reads: "Intended to polymerize dental restorative resins". FDA records list 2 510(k) clearances for Lumendo AG, from to . As of , FDA records show no recalls naming K232076.

Clearance record

Decision date
Received
(112 days to decision)
Product code
QNF Laser Activator For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Lumendo AG Chemin Du Closel 5, Renens, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNF

Trailing 12 months

FDA records hold no clearances under product code QNF in the trailing twelve months.

FDA records show no clearances under product code QNF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260