The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios Sa with the FDA for Mri Compatibility For Existing Neodent Implant System.
| Device ID | K182620 |
| 510k Number | K182620 |
| Device Name: | MRI Compatibility For Existing Neodent Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJGC Industria E Comercio De Materiais Dentarios SA Av. P. Juscelino Kubitschek De Oliveira, 3291 Curitiba, BR 81270-200 |
| Contact | Julianne Lachechem |
| 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 | 2018-09-24 |
| Decision Date | 2019-01-18 |