The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Intracam.
| Device ID | K972033 |
| 510k Number | K972033 |
| Device Name: | PLANMECA INTRACAM |
| Classification | Unit, Operative Dental |
| Applicant | PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-06-20 |