The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Dimer Acid Derived Nano-hybrid Composite Restorative Material.
| Device ID | K072150 |
| 510k Number | K072150 |
| Device Name: | DIMER ACID DERIVED NANO-HYBRID 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 | 2007-08-03 |
| Decision Date | 2007-09-13 |
| Summary: | summary |