# K152615: Vonflex S

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Nov 3, 2016 after 416 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: 4 generations back to K943574 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113406: Aquasil  Ultra Smart Wetting Impression Material, Dentsply International, Inc. (2012) Summary page 4.

## Most influential descendants
- K233954: Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (2024), 0 descendants of its own
- K222741: DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set (Regular, Fast) (2022), 0 descendants of its own

## Indications for use
- Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions - Impression of inlay, crown, bridge and partial denture etc.

Source page: https://510kreport.com/device/K152615
Methodology: https://510kreport.com/methodology