PROSTYLE INTRA
Device Facts
| Record ID | K970975 |
|---|---|
| Device Name | PROSTYLE INTRA |
| Applicant | Planmeca Oy |
| Product Code | EHD · Dental |
| Decision Date | Apr 1, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.1800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An extraoral source x-ray system is an AC-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 outside the mouth. This generic type of device may include patient and equipment supports and component parts.
