FDA Device Establishments · JSON-LD · Markdown
FEI 3006946041 · Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3006946041 |
|---|---|
| Owner / Operator | OSSTEM ORTHODONTICS Inc. (#10050607) |
| Address | (Ojeon-dong, Byeoksantechnopia) A-1203, 1204, 13 Ojeongongeop-gil,, Uiwang-si Gyeonggi, 16072, KR |
| Mandatory US Agent | J.S.Chem International Co. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EJF |
| Regulation § (21 CFR) | 872.5410 |
| Proprietary names | Sensation M; MAJESTY-SLM; YES2; MAJESTY Tube; Dr. Unbong's M-P Tube(Molar Protraction Tube); SM Tube |
Source: openFDA. Public-domain (CC0).