The following data is part of a premarket notification filed by 3disc Americas with the FDA for Firecr Dentalimaging System.
| Device ID | K131442 |
| 510k Number | K131442 |
| Device Name: | FIRECR DENTALIMAGING SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | 3DISC AMERICAS 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm 3DISC AMERICAS 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2013-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809466040214 | K131442 | 000 |