# K103164: Vonflex Heavy, Vinflex Light

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Nov 10, 2010 after 14 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: 3 generations back to K943574 (1994). 4 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021413: Aquasil Ultra Rigid Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 1.
- K021416: Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 1.

## Most influential descendants
- K152766: CharmFlex (2016), 12 descendants of its own
- K170736: HySil Impression Materials (2017), 10 descendants of its own
- K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (2022), 2 descendants of its own
- K192941: HySil Super Fast Impression Materials (2020), 2 descendants of its own
- K181236: HySil Impression Materials (2018), 1 descendant of its own

## Indications for use
- Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions - All impression techniques where the operator needs a heavy or low viscosity material

Source page: https://510kreport.com/device/K103164
Methodology: https://510kreport.com/methodology