# K042878: Flexitime Xtreme

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Dec 17, 2004 after 60 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101617: Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge Refill (2010), 1 descendant of its own
- K134008: MD-Flex Heavy Body (2014), 0 descendants of its own

## Indications for use
Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

Source page: https://510kreport.com/device/K042878
Methodology: https://510kreport.com/methodology