Data / Medical devices / South Korea / Shinhung Co. Ltd.
Shinhung Co. Ltd.: FDA-registered device maker in Ansan-si Gyeonggi, South Korea, 2 510(k) clearances
Shinhung Co. Ltd. is registered with the FDA (registration 9710613) in Ansan-si Gyeonggi, South Korea. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710613
- FEI number
- 3000199218
- Address
- 42-25, 27beon-gil, Dongsan-ro, Danwon-gu, Ansan-si Gyeonggi, South Korea, 15433
- Owner or operator
- SHINHUNG CO. LTD. (9046958)
- Roles
- Manufacturer
- First device listed
- December 31, 2003
- Registered through
- 2026
- Brand names listed
- ALU CROWN, Chair-C1, Chair-G7, G7, Dental Operative Unit and Accessories, K-CLAMP, K-irrigator tips, KF94 2D Mask, KF94 3D Mask, KIDS CROWN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 3, 2023 | K213749 | G7, Dental Operative Unit and Accessories | EIA | Substantially Equivalent | Shinhung Company, Ltd. | accessdata.fda.gov |
| January 22, 2016 | K151996 | TAURUS C1 | EIA | Substantially Equivalent | Shinhung Company, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Dental, Without Operative Unit
- All makers of Accessory, Surgical Apparel
- All makers of Unit, Operative Dental
- All makers of Crown, Preformed
- All makers of Needle, Dental
- All makers of Clamp, Rubber Dam
Updated April 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.