The following data is part of a premarket notification filed by Dentimax, Inc with the FDA for Opensensorx Series.
| Device ID | K220556 |
| 510k Number | K220556 |
| Device Name: | OpenSensorX Series |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | DentiMax, Inc 4115 E Valley Auto Dr, Suite 101 Mesa, AZ 85298 |
| Contact | David Arnett |
| Correspondent | David Arnett DentiMax, Inc 4115 E Valley Auto Dr, Suite 101 Mesa, AZ 85298 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-04-13 |