FDA Device Establishments · JSON-LD · Markdown
FEI 3000278038 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 3000278038 |
|---|---|
| Owner / Operator | ODONTIT SA (#9012625) |
| Address | Necochea 854, BUENOS AIRES Buenos Aires, Ciudad Autonoma de, 1158, AR |
| Mandatory US Agent | ORTHOSURCE, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GCY |
| Regulation § (21 CFR) | 878.4680 |
| Proprietary names | ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE |
Source: openFDA. Public-domain (CC0).