The following data is part of a premarket notification filed by Trident S.r.l with the FDA for I-view Gold And Imagen Gold Dental Sensors.
| Device ID | K200625 |
| 510k Number | K200625 |
| Device Name: | I-View Gold And Imagen Gold Dental Sensors |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Trident S.r.l Via Artigiani 4 Castenedolo, IT 25014 |
| Contact | Giorgio Rizzo |
| Correspondent | Joyce St. Germain The 510K Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2020-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08055060430290 | K200625 | 000 |
| 08055060430412 | K200625 | 000 |
| 08055060430405 | K200625 | 000 |