The following data is part of a premarket notification filed by Trophy with the FDA for Cs 8100 3d.
| Device ID | K133406 |
| 510k Number | K133406 |
| Device Name: | CS 8100 3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Contact | Marie Pierre |
| Correspondent | Marie Pierre TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-06 |
| Decision Date | 2014-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155500329 | K133406 | 000 |
| 60192155500312 | K133406 | 000 |
| 60192155942129 | K133406 | 000 |