F-11 REFLECTOR / F-II STANDARD REFLECTOR
Device Facts
| Record ID | K863019 |
|---|---|
| Device Name | F-11 REFLECTOR / F-II STANDARD REFLECTOR |
| Applicant | Sds Dental, Inc. |
| Product Code | EAZ · Dental |
| Decision Date | Sep 29, 1986 |
| 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.