FDA Device Establishments · JSON-LD · Markdown
FEI 3010564008 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3010564008 |
|---|---|
| Owner / Operator | DENKEN-HIGHDENTAL Co., Ltd. (#10045737) |
| Address | 24-3 Kisshoin Ishiharakyomichi-Cho, Minami-ku, Kyoto, 601-8356, JP |
| Mandatory US Agent | FDC Services LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EIH |
| Regulation § (21 CFR) | 872.6660 |
| Proprietary names | KDF Zirconia Disc |
Source: openFDA. Public-domain (CC0).