Data / Medical devices / China / Northstar Trade Co., Limited
Northstar Trade Co., Limited: FDA-registered device maker in Mongkok KL Hong Kong, China, 1 510(k) clearance
Northstar Trade Co., Limited is registered with the FDA (registration 3027650644) in Mongkok KL Hong Kong, China. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027650644
- Address
- Unit C 2/F Kwong on Bank Mongkok Branch Building Nathan Road, Mongkok KL Hong Kong, China, 999077
- Owner or operator
- Northstar Trade Co., Limited (10088449)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- July 25, 2023
- Registered through
- 2026
- Brand names listed
- SunClear Aligner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Exporter to the US | accessdata.fda.gov |
| Bracket, Plastic, Orthodontic | DYW | 2 | Exporter to the US | accessdata.fda.gov |
| Dentures, Full | NSL | N | Foreign private label distributor | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Foreign private label distributor | accessdata.fda.gov |
| Prosthesis, Orthodontic | NSR | N | Foreign private label distributor | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Foreign private label distributor | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Foreign private label distributor | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Foreign private label distributor | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Foreign private label distributor | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Foreign private label distributor | accessdata.fda.gov |
| Tray, Fluoride, Disposable | KMT | 1 | Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| December 16, 2019 | K190394 | SunClear Aligner system | NXC | Substantially Equivalent | Sun Dental Laboratories, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Bracket, Plastic, Orthodontic
- All makers of Aligner, Sequential
- All makers of Restoration, Porcelain
- All makers of Restoration, Noble Metal
- All makers of Dentures, Full
- All makers of Restoration, Porcelain-Fused-To-Metal
Updated December 16, 2019. 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.