FDA Device Establishments · JSON-LD · Markdown
FEI 3015980207 · Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3015980207 |
|---|---|
| Owner / Operator | Osstem Implant Co., Ltd. Chair Business (#10050476) |
| Address | 192, Haebong-ro, Danwon-gu, Ansan-si Gyeonggi, 15428, KR |
| Mandatory US Agent | HIOSSEN, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EAP |
| Regulation § (21 CFR) | 872.1810 |
| Proprietary names | S2 (digital intra-oral X-ray sensor) |
Source: openFDA. Public-domain (CC0).