The following data is part of a premarket notification filed by Software Nemotec S.l. with the FDA for Nemocast.
| Device ID | K193003 | 
| 510k Number | K193003 | 
| Device Name: | NemoCast | 
| Classification | Orthodontic Software | 
| Applicant | Software Nemotec S.L. Juan De La Cierva Street, 66 Arroyomolinos, Madrid, ES 28939 | 
| Contact | Carlos Arias | 
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 | 
| Product Code | PNN | 
| CFR Regulation Number | 872.5470 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2019-10-28 | 
| Decision Date | 2020-06-05 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  NEMOCAST  79366270  not registered Live/Pending | SOFTWARE NEMOTEC S.L. 2023-01-17 |