The following data is part of a premarket notification filed by Edlen Imaging Llc with the FDA for Edleni Intra-oral Sensor.
| Device ID | K150823 |
| 510k Number | K150823 |
| Device Name: | EDLENi Intra-Oral Sensor |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | EDLEN IMAGING LLC 16441 NORTH 91ST STREET SUITE 102 Scottsdale, AZ 85250 |
| Contact | Nick Radachi |
| Correspondent | Nick Radachi EDLEN IMAGING LLC 16441 NORTH 91ST STREET SUITE 102 Scottsdale, AZ 85250 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-27 |
| Decision Date | 2015-08-26 |
| Summary: | summary |