QNF · Laser Activator For Polymerization
Dental · 21 CFR 872.6070 · Class 2
Overview
| Product Code | QNF |
|---|---|
| Device Name | Laser Activator For Polymerization |
| Regulation | 21 CFR 872.6070 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232076 | Fibercure | Lumendo AG | Nov 2, 2023 | SESE |
| K201904 | Monet Curing Laser | CAO Group, Inc. | Nov 24, 2020 | SESE |
Top Applicants
- CAO Group, Inc. — 1 clearance
- Lumendo AG — 1 clearance
