FDA device listing
MASTERtorque LUX M8900 L; 1.011.2330 - MASTERtorque Mini Kids-Edition en; 3.001.0000 - MASTERtorque Mini LUX M8700 L; 3.
FDA device listing 1753133844 · Patterson Companies, Inc.
Key facts
| Proprietary names | MASTERtorque LUX M8900 L; 1.011.2330 - MASTERtorque Mini Kids-Edition en; 3.001.0000 - MASTERtorque Mini LUX M8700 L; 3. |
|---|---|
| Owner/operator | Patterson Companies, Inc. |
| Owner/operator number | 9921026 |
| Premarket submissions | K130560 |
| Product codes | EFB |
| Device names | EFB - Handpiece, Air-Powered, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | Patterson Dental Canada Inc. |
| Establishment registrations | 3000219976 |
| FEI numbers | 3000219976 |
| Establishment operations | Foreign Exporter |
| 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