The following data is part of a premarket notification filed by Talladium España, Sl with the FDA for Dynamic Tibase.
| Device ID | K212108 |
| 510k Number | K212108 |
| Device Name: | Dynamic TiBase |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Talladium España, SL C/ Virginia Woolf, 17 Lleida, ES 25005 |
| Contact | Xavier Soca Filella |
| Correspondent | Kevin A. 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 | 2021-07-06 |
| Decision Date | 2021-09-24 |