# K231559: Multi-Unit DAS System

- Pathway: 510(k) (Traditional)
- Applicant: Talladium España, SL
- Decided: Nov 17, 2023 after 171 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.
1 later device descends from it; 1 cites it directly.
0 of 327 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
- K243732: Multi-Unit DAS System (2026), 0 descendants of its own

## Indications for use
Multi-Unit DAS System 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 Astra Tech OsseoSpeed TX: implant body diameter 3.5 mm, implant platform 3.5/4.0 mm; implant body diameter 4.0 mm, implant platform 3.5/4.0 mm. Biomet 3i OSSEOTITE® Certain®: implant body diameter 3.25 mm, implant platform 3.4 mm; implant body diameter 4.0 mm, implant platform 4.1 mm. MegaGen AnyRidge: implant body diameter 3.5, 4.0, 4.4, 4.9, 5.4 mm; implant platform 3.5 mm. NobelActive®: implant body diameter 3.5 mm, implant platform 3.5 (NP) mm; implant body diameter 4.3, 5.0 mm, implant platform 3.9 (RP) mm. Zimmer Tapered Screw-Vent®: implant body diameter 3.7, 4.1 mm, implant platform 3.5 mm. All digitally designed custom abutments for use with Multi-Unit DAS System abutments are to be sent to a Talladium validated milling center for manufacture.

Source page: https://510kreport.com/device/K231559
Methodology: https://510kreport.com/methodology