The following data is part of a premarket notification filed by Dentimax with the FDA for Dentimax Digital X-ray Imaging System Sensor Size 1, 2, Dentimax Usb Control Box.
| Device ID | K092547 |
| 510k Number | K092547 |
| Device Name: | DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | DENTIMAX 6965 EL CAMINO REAL SUITE 105-482 Carlsbad, CA 92009 |
| Contact | Korina A Akhondzadeh |
| Correspondent | Korina A Akhondzadeh DENTIMAX 6965 EL CAMINO REAL SUITE 105-482 Carlsbad, CA 92009 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2009-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861572000313 | K092547 | 000 |
| 00861572000306 | K092547 | 000 |