FDA Device Establishments · JSON-LD · Markdown
FEI 3033519161 · Manufacture Medical Device · Status: Active
| FEI Number | 3033519161 |
|---|---|
| Owner / Operator | 8dent Inc. (#10091412) |
| Address | 20-13, Seogimhaesandan-ro, Gimhae-si Gyeongnam, 50967, KR |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DZE, NHA |
| Regulation § (21 CFR) | 872.3640, 872.3630 |
| Proprietary names | 8plant Implant System - BM3510; 8plant Implant System - BR5008N; 8plant Implant System - SUHLM4005; 8plant Implant System - SUHLM4509; 8plant Implant System - SUHLR4503; 8plant Implant System - SUHLR7006; 8plant Implant System - SUHLR8010; 8plant Implant System - SUOPM405540; 8plant Implant System - SUOPR407010; 8plant Implant System - SUOPR454070 |
Source: openFDA. Public-domain (CC0).