FDA Device Establishments · JSON-LD · Markdown
FEI 3015383403 · Manufacture Medical Device · Status: Active
| FEI Number | 3015383403 |
|---|---|
| Owner / Operator | Alpha Dent Implants GmbH (#10086730) |
| Address | Hanauer strasse 1-5, Pforzheim Baden-Wurttemberg, 75181, DE |
| Mandatory US Agent | Registrar Corp |
| 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 | HCAEK Healing Cap for Aesthetic Abutment Konus; ISPA 3.5x16 Implant Superior Active 0 3.5 L 16; ISPA 4x8 Implant Superior Active 0 4 L 8; ISPA 5x8 Implant Superior Active 0 5 L 8; ISPA 4x11.5 Implant Superior Active 0 4 L 11.5; ISPA 5x10 Implant Superior Active 0 5 L 10; Wide.Healing CAP 0 8.L-4.5; ISPA 3.5x11.5 Implant Superior Active 0 3.5 L 11.5; Wide Healing CAP 0 5.5 L 7.5; Wide Healing CAP 0 6.5 L 3.5 |
Source: openFDA. Public-domain (CC0).