| K-number | K970975 |
| Device name | PROSTYLE INTRA |
| Applicant | Planmeca Oy |
| Product code | EHD |
| Device class | Class II |
| Decision date | Apr 1, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 872.1800 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov