The following data is part of a premarket notification filed by Bioloren S.r.l. with the FDA for Trilor Disks, Blocks And Arches.
| Device ID | K173643 |
| 510k Number | K173643 |
| Device Name: | Trilor Disks, Blocks And Arches |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Bioloren S.R.L. via Alessandro Volta 59 Saronno, IT 21047 |
| Contact | Ratti Umberto |
| Correspondent | Ratti Umberto Bioloren S.R.L. via Alessandro Volta 59 Saronno, IT 21047 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-27 |
| Decision Date | 2018-02-24 |