# K091494: Flexitime Flow

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Jul 31, 2009 after 72 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 K000629 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K003930: Flextime Magnum 360, Heraeus Kulzer, Inc. (2001) Summary page 1.

## Indications for use
Flexitime Light Flow/Flexitime Medium Flow each 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/K091494
Methodology: https://510kreport.com/methodology