The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S with the FDA for Neodent Implant System- Cm Drive Implants.
| Device ID | K150182 |
| 510k Number | K150182 |
| Device Name: | Neodent Implant System- CM Drive Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S AV.P.JUSCELINO KUBITSCHEK DE OLIVEIRA 3291 Curitiba, BR 81270-200 |
| Contact | Jacson Cambruzzi |
| Correspondent | Christopher Klaczyk Instradent USA 60 Minuteman Road Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-04-23 |
| Summary: | summary |