# K241924: Elastic Impression Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Beijing Okvd Biological Technology, Ltd.
- Decided: Dec 27, 2024 after 179 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 K133071 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133071: Elastic Impression Material, Rizhao Huge Dental Industry Co., Ltd. (2014) Summary page 5.

## Indications for use
An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Source page: https://510kreport.com/device/K241924
Methodology: https://510kreport.com/methodology