FDA device listing
iTero Element 5D,iTero Element 5D, Full barrier sleeve,iTero Element 5D Laptop Configuration,iTero Element 5D Laptop…
FDA device listing 1885016593 · Align Technology, Inc.
Key facts
| Proprietary names | iTero Element 5D,iTero Element 5D, Full barrier sleeve,iTero Element 5D Laptop Configuration,iTero Element 5D Laptop Configuration, Certified Pre-owned,iTero Element 5D Plus,iTero Element 5D Plus Mobile |
|---|---|
| Owner/operator | Align Technology, Inc. |
| Owner/operator number | 9035576 |
| Premarket submissions | K193659 |
| Product codes | NTK |
| Device names | NTK - Light Transmission Caries Detector |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.1745 |
| 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., Align Technology, Ltd. |
| Establishment registrations | 2953749, 3005695824, 3007527669, 3009646999, 3012138716 |
| FEI numbers | 3002519584, 3005695824, 3007527669, 3009646999, 3012138716 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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