FDA device listing
3D Treatment Planning Software - ClinCheck Pro 6,iGo,iGo Plus,Invisalign ART,Invisalign Assist,Invisalign Express…
FDA device listing 1480700459 · Align Technology, Inc.
Key facts
| Proprietary names | 3D Treatment Planning Software - ClinCheck Pro 6,iGo,iGo Plus,Invisalign ART,Invisalign Assist,Invisalign Express 10,Invisalign Express 5,Invisalign First - Comprehensive,Invisalign Full,Invisalign Go,Invisalign Go Express,Invisalign Go Plus,Invisalign i7,Invisalign Lite,Invisalign System - Comprehensive,Invisalign System - Comprehensive Phase 2,Invisalign System - Express,Invisalign System… |
|---|---|
| Owner/operator | Align Technology, Inc. |
| Owner/operator number | 9035576 |
| Premarket submissions | K241412 |
| Product codes | NXC, PNN |
| Device names | NXC - Aligner, Sequential, PNN - Orthodontic Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.5470 |
| Review panels | Dental |
| Registered establishments | Aligntech de Mexico S, de R. L. de C. V., Align Technology AFAB Poland Sp. z o.o., Align Technology de Costa Rica S.R.L, Align Technology, Inc. |
| Establishment registrations | 2953749, 3005695824, 3007527669, 3012138716, 3025237243 |
| FEI numbers | 3002519584, 3005695824, 3007527669, 3012138716, 3025237243 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database