Manufacturer registered with FDA
Hygedent, Inc.
Beijing, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 42014–2021
- Markets registered in
- 66 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Hygedent, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hygedent, Inc. | 4 clearances | 2014–2021 | Below |
| Peru | DIGEMID | Manufacturer | HYGEDENT INC. | 2 | 2022–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Hygedent Inc | 1 | 2019–2019 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HYGEDENT INC | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hygedent Inc | 1 | 2015–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Hygedent Inc. | 1 | 2018–2018 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Hygedent, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | CHROMATICHYGECHROMAHYGEDENTHYGEMAXHYGEPLUSHygePLUS Alginate Impression MaterialVPS Impression Material | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Hygedent, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Apr 2021 | K203824 | VPS Impression Material | ELW Impression Material |
| 4 Sep 2019 | K191034 | VPS Impression Material | ELW Impression Material |
| 26 Jul 2017 | K170812 | HygePLUS Alginate Impression Material | ELW Impression Material |
| 21 May 2014 | K140074 | HYGEDENT ALGINATE IMPRESSION MATERIAL | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HYGEDENT INC.FDA reg. 3011187729 | Beijing, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047045). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.