# K140074: Hygedent Alginate Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Hygedent, Inc.
- Decided: May 21, 2014 after 128 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 K023466 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023466: Tulip Alginate Impression Material, Cavex Holland BV (2002) Summary page 1.

## Most influential descendants
- K170812: HygePLUS Alginate Impression Material (2017), 0 descendants of its own

## Indications for use
Hygedent Alginate Impression Material is irreversible hydrocolloids for dental Impressions used by the dentist to take the anatomical data of the patient's mouth. The device IsIntended to provide models for study and for production of restorative prosthetic devices, such as gold Inlays and dentures.

Source page: https://510kreport.com/device/K140074
Methodology: https://510kreport.com/methodology