The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Starfill 2b Hv (high Viscosity) Rockcore, Model: 90838 And Starfill 2b Lv (low Viscosity), Model: 90150.
| Device ID | K092912 |
| 510k Number | K092912 |
| Device Name: | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
| Contact | Lindsay Tilton |
| Correspondent | Lindsay Tilton DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon, CA 94583 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2009-12-16 |