The following data is part of a premarket notification filed by Nical Spa with the FDA for Nical Smart Micro Cr System For Intraoral Dental Images.
| Device ID | K143703 |
| 510k Number | K143703 |
| Device Name: | NICAL SMART MICRO CR System For Intraoral Dental Images |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | NICAL SPA VIA SOFFREDINI, 43 Milan, IT 20126 |
| Contact | Roberto Niccolucci |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 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 | 2014-12-29 |
| Decision Date | 2015-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056600521355 | K143703 | 000 |
| 08056600521348 | K143703 | 000 |
| 08056600521331 | K143703 | 000 |
| 08056600520037 | K143703 | 000 |
| 08056600520020 | K143703 | 000 |
| 08056600520013 | K143703 | 000 |
| 08056600520006 | K143703 | 000 |