# K232151: Dynamic TiBase

- Pathway: 510(k) (Traditional)
- Applicant: Talladium España, SL
- Decided: Oct 17, 2023 after 90 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: 21 generations back to K960026 (1996). 325 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221966: Dynamic TiBase, Talladium Espana, SL (2022) Summary page 5.

## Most influential descendants
- 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. Compatible Implant Systems Implant Compatibility Implant Body Diameter, mm Implant Platform, mm 3.5,4.0 3.5/4.0 Astra Tech OsseoSpeed TX 4.5,5.0 4.5/5.0 Biomet 3i OSSEOTITE® Certain® 4.0 3.4 4.0,5.0 4.1 MegaGen AnyRidge 4.0,4.4,4.9,5.4 3.5 3.5 3.5(NP) Nobel Biocare NobelActive® 4.3,5.0 3.9 (RP) 5.5 5.1 (WP) 3.7,4.1 3.5 Zimmer Tapered Screw-Vent® 4.7 4.5 6.0 5.7 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/K232151
Methodology: https://510kreport.com/methodology