The following data is part of a premarket notification filed by Talladium Espana, Sl with the FDA for 3.0 Dynamic Tibase.
| Device ID | K162021 |
| 510k Number | K162021 |
| Device Name: | 3.0 Dynamic TiBase |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | TALLADIUM ESPANA, SL PLAZA UTXESA 7 Lleida, ES 25002 |
| Contact | Esteban Xam-mar |
| Correspondent | Luiz Galdino LUIZ GALDINO 28102 Alton Way Castaic, CA 91384 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-21 |
| Decision Date | 2018-05-04 |