The following data is part of a premarket notification filed by Jjgc Indústria E Comércio De Materiais Dentários Sa with the FDA for Nuvo Cf Implant System.
| Device ID | K203309 |
| 510k Number | K203309 |
| Device Name: | NUVO CF Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJGC Indústria E Comércio De Materiais Dentários SA Av. Juscelino Kubitschek De Oliveira, 3291 – CIC Curitiba, BR 81270-200 |
| Contact | Mariana Soares Hartmann |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-10 |
| Decision Date | 2021-07-06 |
| Summary: | summary |