21 CFR 872.1810 — Unit, X-Ray, Intraoral
Dental (DE) · Subpart B—Diagnostic Devices · § 872.1810
Identification
An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EAP | Unit, X-Ray, Intraoral | 2 | 42 | 3rd Party |
