The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios Sa with the FDA for Neodent Implant System - Zirconia Implant System.
| Device ID | K210336 |
| 510k Number | K210336 |
| Device Name: | Neodent Implant System - Zirconia Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJGC Industria E Comercio De Materiais Dentarios SA Av. Juscelino Kubitschek De Oliveira, 3291 – CIC Curitiba, BR 81270-200 |
| Contact | Mariana Soares Hartmann |
| Correspondent | Jennifer M. Jackson StraumannUSA, 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 | 2021-02-05 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878053392 | K210336 | 000 |
| 07899878053200 | K210336 | 000 |
| 07899878053217 | K210336 | 000 |
| 07899878053224 | K210336 | 000 |
| 07899878053231 | K210336 | 000 |
| 07899878053248 | K210336 | 000 |
| 07899878053255 | K210336 | 000 |
| 07899878053262 | K210336 | 000 |
| 07899878053378 | K210336 | 000 |
| 07899878053385 | K210336 | 000 |
| 07899878053194 | K210336 | 000 |