The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Light-activated Low-stress Thiol-ene Composite Restorative Material.
| Device ID | K092501 |
| 510k Number | K092501 |
| Device Name: | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | NOVOCOL, INC. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 |
| Contact | Steve Rudolph |
| Correspondent | Steve Rudolph NOVOCOL, INC. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2009-11-12 |