21 CFR 872.4630 — Light, Operating, Dental
Dental (DE) · Subpart E—Surgical Devices · § 872.4630
Identification
A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EAZ | Light, Operating, Dental | 1 | 23 | |
| EBA | Light, Surgical Headlight | 1 | 10 |
