# K243732: Multi-Unit DAS System

- Pathway: 510(k) (Traditional)
- Applicant: Talladium España, SL
- Decided: Jan 29, 2026 after 421 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). 326 ancestors in all.
No later device cites it as a predicate yet.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231559: Multi-Unit DAS System, Talladium España, SL (2023) Summary page 5.

## Indications for use
Multi-Unit DAS System is 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 Compatible Implant System Implant Platform Implant Body Diameter, mm (Connection) Diameter, mm or Name 3.6 3.6 Astra Tech EV 4.2 4.2 (Internal Taper) 4.8 4.8 Osstem® TS 3.5 Mini Hiossen® ET (Internal Taper) 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 Regular Neodent GM 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 GM (Morse taper) Straumann Bone Level 3.3 NC (CrossFit® Morse Taper) 4.1, 4.8 RC Straumann BLX 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 RB/WB (TorcFit™ Internal Hexalobular) All digitally designed custom abutments for use with Multi-Unit DAS System are to be sent to a Talladium validated milling center for manufacture.

Source page: https://510kreport.com/device/K243732
Methodology: https://510kreport.com/methodology