Miscellaneous devices · 21 CFR 872 Subpart G
Laser Activator for Polymerization
Intended to polymerize dental restorative resins
- Companies listing it
- 33 makers
- Brands and models
- 3
- 510(k) clearances
- 21 in five years
- FDA name
- Laser Activator For Polymerization
510(k) clearances per year, 1976–2026
Companies that list QNF
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Odne AG | Switzerland | Maker | OdneCure · OdneCure Tip | 1 | 2024 |
| CAO Group, Inc. | United States | Maker | — | 13 | 2020 |
| Medency Srl | Italy | Maker | Fibercure | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 2 Nov 2023 | K232076 | Fibercure | Lumendo AG |
| 24 Nov 2020 | K201904 | Monet Curing Laser | CAO Group, Inc. |
Official records: FDA product classification for QNF · 21 CFR 872.6070.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026