# K212108: Dynamic TiBase

- Pathway: 510(k) (Traditional)
- Applicant: Talladium España, SL
- Decided: Sep 24, 2021 after 80 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K960026 (1996). 322 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 332 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202026: Blue Sky Bio CAD-CAM Abutments, Blue Sky Bio, LLC (2020) Summary page 4.

## Most influential descendants
- K221966: Dynamic TiBase (2022), 5 descendants of its own
- K232151: Dynamic TiBase (2023), 2 descendants of its own
- K231559: Multi-Unit DAS System (2023), 1 descendant of its own
- K221673: Bonafix TiBase (2023), 1 descendant of its own
- K243732: Multi-Unit DAS System (2026), 0 descendants of its own

## Indications for use
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. Implant Compatibility Implant Body Diameter, mm Implant Platform, mm 2.7 3.5 3.5 4.0 SPI® CONTACT Dental Implant 3.5 4.5 4.2 5.0 All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Thommen Medical validated milling center for manufacture.

Source page: https://510kreport.com/device/K212108
Methodology: https://510kreport.com/methodology