The following data is part of a premarket notification filed by Trident S.r.l with the FDA for Reader, Viewer, Quickscan Psp.
| Device ID | K160386 |
| 510k Number | K160386 |
| Device Name: | ReadeR, VieweR, QuickScan PSP |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TRIDENT S.R.L VIA VERDI 20 Assago, IT 20090 |
| Contact | Giorgio Rizzo |
| Correspondent | Claude Berthoin DENTERPRISE INTERNATIONAL, INC. 100 EAST GRANADA BLVD SUITE 219 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-11 |
| Decision Date | 2016-03-10 |
| Summary: | summary |