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 |