FDA Device Establishments · JSON-LD · Markdown
FEI 3007031098 · Manufacture Medical Device · Status: Active
| FEI Number | 3007031098 |
|---|---|
| Owner / Operator | Dentis Co., Ltd. (#10025697) |
| Address | 99, Seongseoseo-ro, Dalseo-Gu, Daegu, 42718, KR |
| Mandatory US Agent | Withus Group Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DZE |
| Regulation § (21 CFR) | 872.3640 |
| Proprietary names | OneQ-SL Implant System |
Source: openFDA. Public-domain (CC0).