FDA product code QNF: Laser Activator For Polymerization
QNF is the FDA product code for laser activator for polymerization. It is a Class II device, regulated under 21 CFR 872.6070 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under QNF, 1 in the last five years, from 2 different applicants. The average 510(k) review took 125 days (median 125).
Definition
Intended to polymerize dental restorative resins
Classification
| Field | Value |
|---|---|
| Device name | Laser Activator For Polymerization |
| Device class | Class II |
| Regulation | 21 CFR 872.6070 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for QNF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 138 |
| 2023 | 1 | 112 |
Compare with all 510(k) review times · Search every QNF clearance
Top QNF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lumendo AG | 1 | 2023-11-02 |
| CAO Group, Inc. | 1 | 2020-11-24 |
Most recent QNF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232076 | Lumendo AG | Fibercure | 2023-11-02 | 112 |
| K201904 | CAO Group, Inc. | Monet Curing Laser | 2020-11-24 | 138 |
Recalls for QNF devices
openFDA lists no recalls for product code QNF.
Frequently asked questions
What is FDA product code QNF?
QNF is the FDA product code for laser activator for polymerization. It is a Class II device, regulated under 21 CFR 872.6070 and reviewed by the Dental panel.
What device class is QNF?
Class II, regulation 21 CFR 872.6070. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNF?
Across 2 cleared submissions the average was 125 days from receipt to decision (median 125).
Which companies have the most QNF clearances?
Lumendo AG (1); CAO Group, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QNF
- Run a recall and safety report across every QNF manufacturer
- Watch product code QNF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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