# K222741: DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), DENU Putty Set (Regular, Fast)

- Pathway: 510(k) (Traditional)
- Applicant: Hdi, Inc.
- Decided: Nov 7, 2022 after 59 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: 5 generations back to K943574 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152615: Vonflex S, Vericom Co., Ltd. (2016) Summary page 4.
- K152518: Vonflex S Putty, Vericom Co., Ltd. (2015) Summary page 4.

## Indications for use
DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression - Denture impression - Model impression DENU Putty Set(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression

Source page: https://510kreport.com/device/K222741
Methodology: https://510kreport.com/methodology