The following data is part of a premarket notification filed by Talladium Espana, Sl with the FDA for Dynamic Tibase.
| Device ID | K221966 |
| 510k Number | K221966 |
| Device Name: | Dynamic TiBase |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Talladium Espana, SL Virginia Woolf, 17 Lleida, ES 25005 |
| Contact | Xavier Soca Filella |
| Correspondent | Kevin Thomas PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08435673504647 | K221966 | 000 |
| 08435673504630 | K221966 | 000 |
| 08435673504623 | K221966 | 000 |
| 08435673504616 | K221966 | 000 |
| 08435673504609 | K221966 | 000 |
| 08435673504593 | K221966 | 000 |
| 08435673504562 | K221966 | 000 |