FDA device listing
Attachment Template
FDA device listing 1153969597 · Align Technology, Inc.
Key facts
| Proprietary names | Attachment Template |
|---|---|
| Owner/operator | Align Technology, Inc. |
| Owner/operator number | 9035576 |
| Product codes | QJJ |
| Device names | QJJ - Indirect Bonding Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.5410 |
| 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, Specification Developer, Manufacturer |
| 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