The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S.a. with the FDA for Neodent Implant System.
| Device ID | K190958 |
| 510k Number | K190958 |
| Device Name: | Neodent Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJGC Industria E Comercio De Materiais Dentarios S.A. 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 | 2019-04-12 |
| Decision Date | 2019-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878031963 | K190958 | 000 |
| 07899878031956 | K190958 | 000 |
| 07899878031949 | K190958 | 000 |
| 07899878031932 | K190958 | 000 |
| 07899878031925 | K190958 | 000 |
| 07899878031871 | K190958 | 000 |