The following data is part of a premarket notification filed by Nanova Biomaterials Inc with the FDA for Nanova 2 Step Etch And Rinse Dental Adhesive, Nanova Etchant Gel.
| Device ID | K172977 |
| 510k Number | K172977 |
| Device Name: | Nanova 2 Step Etch And Rinse Dental Adhesive, Nanova Etchant Gel |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Nanova Biomaterials Inc 3806 Mojave Ct Columbia, MO 65202 |
| Contact | Andrew C. Ritts |
| Correspondent | Andrew C. Ritts Nanova Biomaterials Inc 3806 Mojave Ct Columbia, MO 65202 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-01-16 |
| Summary: | summary |