The following data is part of a premarket notification filed by Implacil De Bortoli Material Odontologico Ltda with the FDA for Implacil Implant System.
| Device ID | K183024 |
| 510k Number | K183024 |
| Device Name: | Implacil Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Implacil De Bortoli Material Odontologico Ltda Rua Vicente De Carvalho 178-182 Sao Paulo, BR 01521020 |
| Contact | Thiago Toni |
| Correspondent | Janine Treter PR Servicos Regulatorios Administrativos Ltda Rua Alice Além Saadi, 855/ 2402 Ribeirão Preto, BR 14096-570 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2020-02-13 |