CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676
Device Facts
| Record ID | K942198 |
|---|---|
| Device Name | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 |
| Applicant | Rolence Enterprise Co. , Ltd. |
| Product Code | EBZ · Dental |
| Decision Date | May 27, 1994 |
| 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.
