The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Promax 3d Max, Planmeca Maximity.
| Device ID | K160506 |
| 510k Number | K160506 |
| Device Name: | Planmeca ProMax 3D Max, Planmeca Maximity |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-05-20 |
| Summary: | summary |