Q-LUX PLASMA 100 LIGHT CURE UNIT
Device Facts
| Record ID | K001719 |
|---|---|
| Device Name | Q-LUX PLASMA 100 LIGHT CURE UNIT |
| Applicant | Rolence Enterprise Co. , Ltd. |
| Product Code | EBZ · Dental |
| Decision Date | Oct 10, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6070 |
| Device Class | Class 2 |
Regulatory Classification
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.
