# K101617: Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge Refill

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: Sep 7, 2010 after 90 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: 1 generation back to K042878 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042878: Flexitime Xtreme, Heraeus Kulzer, Inc. (2004) Summary page 1.

## Most influential descendants
- K134008: MD-Flex Heavy Body (2014), 0 descendants of its own

## Indications for use
Flexitime Xtreme 2 is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.

Source page: https://510kreport.com/device/K101617
Methodology: https://510kreport.com/methodology