# K130647: Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50ML

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: May 17, 2013 after 67 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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 K000629 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000629: Flextime, Heraeus Kulzer, Inc. (2000) Summary page 1.
- K113574: Flexitime Monophase Pro Scan, Heraeus Kulzer, LLC (2012) Summary page 2.

## Indications for use
Xantasil is a medium flow, addition-curing, elastomer dental impression material that can be used to cover all impression needs where a traditional alginate material would be used, such as impressions for temporaries, crown and bridges, removable dentures, orthodontic models, opposing jaw models, splints, mouth guards and bleaching trays. It is used to get 6 negative copy of the patients' dental situation.

Source page: https://510kreport.com/device/K130647
Methodology: https://510kreport.com/methodology