The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Dimex 2.
| Device ID | K000454 |
| 510k Number | K000454 |
| Device Name: | DIMEX 2 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | PLANMECA OY 362 BALM COURT Wood Dale, IL 60191 -1273 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMECA OY 362 BALM COURT Wood Dale, IL 60191 -1273 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-03-31 |