KULZER TRANSLUX EC
Device Facts
| Record ID | K892456 |
|---|---|
| Device Name | KULZER TRANSLUX EC |
| Applicant | Kulzer, Inc. |
| Product Code | EBZ · Dental |
| Decision Date | Jun 14, 1989 |
| 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.
