SPECULITE/ORALLITE
Device Facts
| Record ID | K003995 |
|---|---|
| Device Name | SPECULITE/ORALLITE |
| Applicant | Trylon Corp. |
| Product Code | EAZ · Dental |
| Decision Date | Mar 16, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4630 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.
