# K143104: Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Mar 25, 2015 after 147 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872510 (1987). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012307: Luxacore/Luxacore Dual, Dmg USA, Inc. (2001) Summary page 5.
- K040795: Multicore HB; Multicore Flow, Ivoclar Vivadent, Inc. (2004) Summary page 5.
- K060893: Modification to Rebilda DC, Voco GmbH (2006) Summary page 9.

## Most influential descendants
- K191527: Visalys CemCore, Visalys Cem Core Try In Paste (2019), 0 descendants of its own

## Indications for use
Visalys® Core, PL-Core, PL-Core-C, PL-Core-X are dual-curing core build-up materials which are intended to be used for different types of core build-ups and luting of root posts

Source page: https://510kreport.com/device/K143104
Methodology: https://510kreport.com/methodology