FDA Device Establishments · JSON-LD · Markdown
FEI 3031886796 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3031886796 |
|---|---|
| Owner / Operator | Osstem Implant Co., Ltd. (#10089729) |
| Address | 3, Magokjungang 12-ro, Gangseo-gu Seoul, 07789, KR |
| Mandatory US Agent | HIOSSEN, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DZA |
| Regulation § (21 CFR) | 872.4130 |
| Proprietary names | AutoBone Collector; Initial Drills; One485 Drills; Three Cutter Drills; 485 Drills; Cortical Drills; Long Shank Pilot Drill; Path Drills; Orthodontic Drills; Guide Drills |
Source: openFDA. Public-domain (CC0).