# K241170: Dynamic TiBase; TRI Screws

- Pathway: 510(k) (Traditional)
- Applicant: Talladium España, SL
- Decided: Oct 21, 2024 after 178 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: 22 generations back to K960026 (1996). 336 ancestors in all.
No later device cites it as a predicate yet.
0 of 337 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232151: Dynamic TiBase, Talladium España, SL (2023) Summary page 5.
- K203660: TRI-matrix Implant Line, Tri Dental Implants Int. AG (2021) Summary page 5.

## Indications for use
Dynamic TiBase abutments are intended for use with dental implants as a support for single-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 Diameter, name (mm) SGS P1D Conical | 5.0 | 3.5 (3.0 mm) SGS P7N Narrow Conical | 3.2 | 2.1 (2.5 mm) All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium validated milling center for manufacture. TRI Screws are intended to secure TRI-matrix® Crown Abutments to TRI-matrix® implants.

Source page: https://510kreport.com/device/K241170
Methodology: https://510kreport.com/methodology