Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose…
Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose Throat) regions.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).
Record
Regulatory record for Planmeca ProMax | Listed by | Planmeca Oy, Finland |
| FDA product code | OAS |
| Device type | X-Ray, Tomography, Computed, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Manufacturer |
| Record published | 2016-09-19 |
| Record revised | 2023-11-20 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2021-01-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.