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- Gm Titanium Base For Bridge.
| Device ID | K192229 |
| 510k Number | K192229 |
| Device Name: | Neodent Implant System- GM Titanium Base For Bridge |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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, INC. 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 | 2019-08-16 |
| Decision Date | 2019-12-19 |