FDA device listing
Invisalign Impression Tray Large Lower,Invisalign Impression Tray Large Upper,Invisalign Impression Tray Medium…
FDA device listing 1415314645 · Align Technology, Inc.
Key facts
| Proprietary names | Invisalign Impression Tray Large Lower,Invisalign Impression Tray Large Upper,Invisalign Impression Tray Medium Lower,Invisalign Impression Tray Medium Upper,Invisalign Impression Tray Small Lower,Invisalign Impression Tray Small Upper,Invisalign Impression Tray X-Large Lower,Invisalign Impression Tray X-Large Upper |
|---|---|
| Owner/operator | Align Technology, Inc. |
| Owner/operator number | 9035576 |
| Product codes | EHY |
| Device names | EHY - Tray, Impression, Preformed |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6880 |
| Review panels | Dental |
| Registered establishments | Aligntech de Mexico S, de R. L. de C. V., Align Technology de Costa Rica S.R.L, Align Technology, Inc. |
| Establishment registrations | 2953749, 3005695824, 3007527669, 3012138716 |
| FEI numbers | 3002519584, 3005695824, 3007527669, 3012138716 |
| Establishment operations | Complaint File Establishment, Specification Developer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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