FDA Device Establishments · JSON-LD · Markdown
FEI 3003136642 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3003136642 |
|---|---|
| Owner / Operator | DENTSPLY SIRONA INC (#2511302) |
| Address | Rungestrasse 19, Berlin Brandenburg, 10179, DE |
| Mandatory US Agent | DENTSPLY SIRONA INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EIA |
| Regulation § (21 CFR) | 872.6640 |
| Proprietary names | SureSmile Aligner Software v 7.6; SureSmile Advanced Software v 7.6; SureSmile Ortho Software v 7.6 |
Source: openFDA. Public-domain (CC0).