Data / Medical devices / South Korea / HT Co., Ltd.
HT Co., Ltd.: FDA-registered device maker in Yongin-si Gyeonggi, South Korea, 1 510(k) clearance
HT Co., Ltd. is registered with the FDA (registration 3005256634) in Yongin-si Gyeonggi, South Korea. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 25, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005256634
- Address
- 10, Sinjeong-ro 159beon-gil Giheung-gu, Yongin-si Gyeonggi, South Korea, 16945
- Owner or operator
- HT Co., Ltd. (10028610)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 17, 2009
- Registered through
- 2026
- Brand names listed
- Cross-M, Cross-MD, Cross-MH, Cross-MW, MISO Coil Spring Stainless Steel Closed Colil Spring MSCS1030, MISO Coil Spring Stainless Steel Open Coil Spring MSOS1030, MISO DEBONDING PLIER HT-001, MISO NiTi Closed Coil Spring Heavy MCS15-13H and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Ceramic, Orthodontic | NJM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tip, Rubber, Oral Hygiene | JEW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 25, 2011 | K102561 | ORTHODONTIC CERAMIC BRACKET | NJM | Substantially Equivalent | Ht Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Oral Irrigation
- All makers of Tip, Rubber, Oral Hygiene
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Wire, Orthodontic
- All makers of Spring, Orthodontic
- All makers of Bracket, Metal, Orthodontic
Updated January 25, 2011. 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.