DeviceClearance

Product code QNF— Dental

Fibercure

Classification name
Laser Activator For Polymerization
Device class
Class 2
Regulation
21 CFR 872.6070
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

FDA classification definition

“Intended to polymerize dental restorative resins”

— U.S. Food and Drug Administration, device classification record for product code QNF under 21 CFR 872.6070, via openFDA

Market context for product code QNF

FDA has cleared 2 devices under product code QNF between 2020 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNF

Recent clearances under product code QNF

Data sourced from openFDA. This site is unofficial and independent of the FDA.