The following data is part of a premarket notification filed by Danville Materials Inc. with the FDA for Siljetr System.
| Device ID | K110642 |
| 510k Number | K110642 |
| Device Name: | SILJETR SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DANVILLE MATERIALS INC. 3420 FOSTORIA WAY ST. A-200 San Ramon, CA 94583 |
| Contact | Lindsay Tilton |
| Correspondent | Lindsay Tilton DANVILLE MATERIALS INC. 3420 FOSTORIA WAY ST. A-200 San Ramon, CA 94583 |
| Product Code | EBF |
| Subsequent Product Code | KLE |
| Subsequent Product Code | KOJ |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-07 |
| Decision Date | 2011-05-27 |