# K201483: Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou Huaer Electro Optics Technology Co., Ltd.
- Decided: Oct 8, 2020 after 126 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: 2 generations back to K103346 (2011). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152518: Vonflex S Putty, Vericom Co., Ltd. (2015) Summary page 4.

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

## Indications for use
Used for all crown, bridge, and orthodontic impression techniques.

Source page: https://510kreport.com/device/K201483
Methodology: https://510kreport.com/methodology