# K102770: Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium Flow

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: Dec 21, 2010 after 88 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.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Flexitime Dynamix Putty: named in the summary without a submission number
- (no number) Flexitime Light Flow: named in the summary without a submission number
- (no number) Flexitime Medium Flow: named in the summary without a submission number

## Most influential descendants
- K113574: Flexitime Monophase Pro Scan (2012), 1 descendant of its own
- K130647: Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50ML (2013), 0 descendants of its own
- K120914: Flexitime Fast & Scan Light Flow (2012), 0 descendants of its own

## Indications for use
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, edentulous and partial impression. The Flexitime Fast & Scan range products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 Shape 0700 laser scanners.

Source page: https://510kreport.com/device/K102770
Methodology: https://510kreport.com/methodology