# K113574: Flexitime Monophase Pro Scan

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: Jul 13, 2012 after 224 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102770: Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium Flow, Heraeus Kulzer, LLC (2010) Summary page 1.
- K000629: Flextime, Heraeus Kulzer, Inc. (2000) Summary page 2.

## Most influential descendants
- K130647: Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50ML (2013), 0 descendants of its own

## Indications for use
It is used to get an exact negative copy of the patient's dental situation and can be used for optical scanning in dental scanners designed for scanning impression material.

Source page: https://510kreport.com/device/K113574
Methodology: https://510kreport.com/methodology