The following data is part of a premarket notification filed by Jj Industria E Comercio De Materiais Dentarios Sa with the FDA for Neodent Implant System.
| Device ID | K133510 |
| 510k Number | K133510 |
| Device Name: | NEODENT IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA 11264 EL CAMINO REAL, SUITE 400 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA 11264 EL CAMINO REAL, SUITE 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-14 |
| Decision Date | 2014-02-24 |
| Summary: | summary |