# K152518: Vonflex S Putty

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Nov 30, 2015 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
Longest line of descent: 1 generation back to K103346 (2011). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103346: Delikit Putty, Delikit Heavy Body, Delikit Light Body, Sherpa Korea (2011) Summary page 4.

## Most influential descendants
- K201483: Impression Material (2020), 2 descendants of its own
- K211489: Dental Impression Material (2021), 1 descendant 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
- K221668: Dental Impression Material (2022), 0 descendants of its own

## Indications for use
It is used for all crown, bridge and orthodontic impression techniques.

Source page: https://510kreport.com/device/K152518
Methodology: https://510kreport.com/methodology