FDA Device Establishments · JSON-LD · Markdown
FEI 3012138716 · Manufacture Medical Device · Status: Active
| FEI Number | 3012138716 |
|---|---|
| Owner / Operator | Align Technology, Inc. (#9035576) |
| Address | Avenida Intermex # 1357, Parque Industrial Intermex, Cd. Juarez Chihuahua, 32575, MX |
| Mandatory US Agent | Align Technology, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NXC |
| Regulation § (21 CFR) | 872.5470 |
| Proprietary names | Invisalign First-Moderate; Invisalign I7; Invisalign Express 5; Invisalign Full; Invisalign System - Moderate; 3D Treatment Planning Software - ClinCheck Pro 6; Invisalign System with Mandibular Advancement Precision Wings; Invisalign System-Comprehensive Phase 2; Invisalign System Orthodontic Appliance; Invisalign Swift |
Source: openFDA. Public-domain (CC0).