The following data is part of a premarket notification filed by Nanova Biomaterials, Inc. with the FDA for Nanova Flowable Composite.
| Device ID | K150623 |
| 510k Number | K150623 |
| Device Name: | Nanova Flowable Composite |
| Classification | Material, Tooth Shade, Resin |
| Applicant | NANOVA BIOMATERIALS, INC. 3806 MOJAVE CT Columbia, MO 65202 |
| Contact | Andrew Ritts |
| Correspondent | Andrew Ritts NANOVA BIOMATERIALS, INC. 3806 MOJAVE CT Columbia, MO 65202 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-06-18 |
| Summary: | summary |