| Primary Device ID | 08055060430955 |
| NIH Device Record Key | 643db1da-f63b-4299-800d-1abc5630a6c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intraoral Digital Impression Instrument |
| Version Model Number | Imagen Scan |
| Catalog Number | TSC002 |
| Company DUNS | 430142798 |
| Company Name | TRIDENT SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com | |
| Phone | 4073191348 |
| marcelo.funk@trident-dental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08055060430955 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-28 |
| Device Publish Date | 2022-07-20 |
| 08055060430955 | Intra oral scanner for digital impression of Dental restoration |
| 08055060430948 | Intra oral scanner for digital impression of Dental restoration |