K193003 is an FDA 510(k) clearance for the NemoCast. This device is classified as a Orthodontic Software (Class II - Special Controls, product code PNN).
Submitted by Software Nemotec S.L. (Arroyomolinos, Madrid, ES). The FDA issued a Cleared decision on June 5, 2020, 221 days after receiving the submission on October 28, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only..
| 510(k) Number | K193003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2019 |
| Decision Date | June 05, 2020 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | PNN - Orthodontic Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only. |