Data / Medical devices / United States / Vitang Technology LLC
Vitang Technology LLC: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Vitang Technology LLC is registered with the FDA (registration 3015549533) in Irvine, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 29, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015549533
- Address
- 15231 Alton Pkwy Ste 120, Irvine, CA, United States, 92618
- Owner or operator
- Vitang Technology LLC (10060585)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- May 29, 2019
- Registered through
- 2026
- Brand names listed
- Teeth Whitening Pen, Unismile Clear Aligner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Repackager or relabeler | 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 29, 2020 | K191837 | UniSmile Clear Aligner System | NXC | Substantially Equivalent | Vitang Technology, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 29, 2020. 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.