# K221966: Dynamic TiBase

- Pathway: 510(k) (Traditional)
- Applicant: Talladium Espana, SL
- Decided: Sep 15, 2022 after 72 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: 20 generations back to K960026 (1996). 324 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212108: Dynamic TiBase, Talladium España, SL (2021) Summary page 4.
- K210220: Kontact Dental Implant System, Biotech Dental, Sas (2021) Summary page 4.

## Most influential descendants
- K232151: Dynamic TiBase (2023), 2 descendants of its own
- K231559: Multi-Unit DAS System (2023), 1 descendant of its own
- K243732: Multi-Unit DAS System (2026), 0 descendants of its own
- K243530: Dynamic TiBase (2025), 0 descendants of its own
- K241170: Dynamic TiBase; TRI Screws (2024), 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: Kontact™ Dental Implant System Implant body diameter / implant platform: 3.6 mm / 3.6 mm; 4.2 mm / 4.2 mm; 4.8 mm / 4.8 mm; 5.4 mm / 5.4 mm. All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium validated milling center for manufacture.

Source page: https://510kreport.com/device/K221966
Methodology: https://510kreport.com/methodology