Hygedent Inc.
Registered establishment in Beijing, China. 1 device type, 4 clearances.
Hygedent Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Material, Impression. Its earliest product listing with the FDA dates from 2014.
1device type
4510(k) clearances
Registration
| Registered name | HYGEDENT INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011187729 |
| FEI number | 3011187729 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 北京海吉雅医疗器材有限公司 |
|---|---|
| Unified social credit code | 91110107802351689U |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Gate E, Building 1, No.97 Changping Road |
| Postal code | 102206 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Material, Impression | Class 2 | Chromatic, Hygemax, Hygechroma, Hygedent, Hygeplus, HygePLUS Alginate Impression Material and 1 more | 2014 | 6 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K203824 | 2021-04-19 | ELW | Traditional | This company |
| K191034 | 2019-09-04 | ELW | Traditional | This company |
| K170812 | 2017-07-26 | ELW | Traditional | This company |
| K140074 | 2014-05-21 | ELW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Main products | Oral impression materials, Alginate impression materials |
| Certifications | ISO 13485 |
| Export markets | US, Japan, South Korea, Brazil |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.