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 | K202282 |
| 510k Number | K202282 |
| Device Name: | Neodent Implant System - Zirconia Implant System |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-12 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878045724 | K202282 | 000 |
| 07899878045717 | K202282 | 000 |
| 07899878045700 | K202282 | 000 |
| 07899878045694 | K202282 | 000 |