The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Promax 3d Max.
| Device ID | K093590 |
| 510k Number | K093590 |
| Device Name: | PLANMECA PROMAX 3D MAX |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-19 |
| Decision Date | 2010-05-12 |
| Summary: | summary |