Data / Medical devices / Hong Kong / Wise Way (HK) Trading Limited
Wise Way (HK) Trading Limited: FDA-registered device maker in Wanchai, Hong Kong, 2 510(k) clearances
Wise Way (HK) Trading Limited is registered with the FDA (registration 3013960456) in Wanchai, Hong Kong. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013960456
- Address
- Unit A, 15 Floor, Sunshine Plaza, 353 Lockhart Rd, Wanchai, Hong Kong, 999077
- Owner or operator
- WISE WAY (HK) TRADING LIMITED (10055803)
- Roles
- Exporter to the US
- First device listed
- October 9, 2017
- Registered through
- 2026
- Brand names listed
- Dentures, full, Dentures, partial, Dynamic Abutment Solutions, Prosthesis, orthodontic, Restoration, base metal, Restoration, noble metal, Restoration, porcelain, Restoration, porcelain fused to metal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Exporter to the US | accessdata.fda.gov |
| Dentures, Full | NSL | N | Exporter to the US | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Exporter to the US | accessdata.fda.gov |
| Prosthesis, Orthodontic | NSR | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Resin | NSM | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Exporter to the US | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| October 17, 2023 | K232151 | Dynamic TiBase | NHA | Substantially Equivalent | Talladium España, SL | accessdata.fda.gov |
| May 4, 2018 | K162021 | 3.0 Dynamic TiBase | NHA | Substantially Equivalent | Talladium Espana, SL | accessdata.fda.gov |
Compare with other makers
- All makers of Restoration, Resin, Crown And Bridge
- All makers of Restoration, Resin
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Restoration, Noble Metal
- All makers of Dentures, Full
- All makers of Restoration, Porcelain-Fused-To-Metal
Updated October 17, 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.