The following data is part of a premarket notification filed by Bicon, Llc with the FDA for Fiber Disks And Blocks (trinia).
| Device ID | K143524 |
| 510k Number | K143524 |
| Device Name: | Fiber Disks And Blocks (TRINIA) |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Bicon, LLC 501 Arborway Boston, MA 02130 |
| Contact | Richard Wu |
| Correspondent | Richard Wu Bicon, LLC 501 Arborway Boston, MA 02130 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110020451 | K143524 | 000 |
| 00813110020345 | K143524 | 000 |
| 00813110020246 | K143524 | 000 |