# K170812: HygePLUS Alginate Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Hygedent, Inc.
- Decided: Jul 26, 2017 after 131 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 K023466 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140074: Hygedent Alginate Impression Material, Hygedent, Inc. (2014) Summary page 5.

## Indications for use
HygePLUS 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 is Intended to provide models for study and for production of restorative prosthetic devices, such as gold Inlays and dentures.

Source page: https://510kreport.com/device/K170812
Methodology: https://510kreport.com/methodology