# Hygedent, Inc.

- Location (FDA's records): Beijing, CN
- FDA decisions: 4 (2014–2021): 4 510(k) clearances
- Product codes: ELW (4)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cavex Holland BV: 1 (https://510kreport.com/company/cavex-holland)
- Discus Dental, Inc.: 1 (https://510kreport.com/company/discus-dental)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)

## Its most-cited devices
- K140074: Hygedent Alginate Impression Material (2014), cited by 1

## Recent decisions
- K203824: VPS Impression Material (Apr 19, 2021)
- K191034: VPS Impression Material (Sep 4, 2019)
- K170812: HygePLUS Alginate Impression Material (Jul 26, 2017)
- K140074: Hygedent Alginate Impression Material (May 21, 2014)

Source page: https://510kreport.com/company/hygedent