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 |