FDA Device Establishments · JSON-LD · Markdown
FEI 3024490167 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device · Status: Active
| FEI Number | 3024490167 |
|---|---|
| Owner / Operator | Gecko Labs, LLC (#10086104) |
| Address | 12110 Tech Center Dr, Ste 1, Poway, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NXC |
| Regulation § (21 CFR) | 872.5470 |
| Proprietary names | GT FLEX Aligners; OraShape Aligners; QuickAligners Aligners |
Source: openFDA. Public-domain (CC0).