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 |