HELIOMAT
Device Facts
| Record ID | K802684 |
|---|---|
| Device Name | HELIOMAT |
| Applicant | Vivadent (Usa), Inc. |
| Product Code | EAY · Dental |
| Decision Date | Nov 24, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4620 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A fiber optic dental light is a device that is a light, usually AC-powered, that consists of glass or plastic fibers which have special optical properties. The device is usually attached to a dental handpiece and is intended to illuminate a patient's oral structures.