FDA Device Establishments · JSON-LD · Markdown
FEI 3005547450 · Manufacture Medical Device · Status: Active
| FEI Number | 3005547450 |
|---|---|
| Owner / Operator | Scheu-Dental GmbH (#8010874) |
| Address | AM BURGBERG 20, ISERLOHN North Rhine-Westphalia, 58642, DE |
| Mandatory US Agent | GREAT LAKES DENTAL TECHNOLOGIES |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KMY |
| Regulation § (21 CFR) | 872.5525 |
| Proprietary names | DURASOFT; UNIQ, UNIQ+; BIOCRYL C; DURASPLINT LC; IMPRELON, IMPRELON S pd, IMPRELON S+ pd; BIOPLAST, BIOPLAST XTREME; DURASOFT, DURASOFT pd; HARDCAST; DURAN, DURAN+; COPYPLAST, COPYPLAST C |
Source: openFDA. Public-domain (CC0).