The following data is part of a premarket notification filed by Inter-med / Vista Dental Products with the FDA for Vista Dyes.
| Device ID | K193447 |
| 510k Number | K193447 |
| Device Name: | Vista Dyes |
| Classification | Device, Caries Detection |
| Applicant | Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
| Contact | Alex Johnson |
| Correspondent | Alex Johnson Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-13 |
| Decision Date | 2020-03-11 |