FDA device listing
ATP38 Miracle
FDA device listing 1138315888 · Biotech Dental
Key facts
| Proprietary names | ATP38 Miracle |
|---|---|
| Owner/operator | Biotech Dental |
| Owner/operator number | 10076527 |
| Product codes | ILY |
| Device names | ILY - Lamp, Infrared, Therapeutic Heating |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5500 |
| Review panels | Physical Medicine |
| Registered establishments | BIOTECH DENTAL SAS |
| Establishment registrations | 3014290448 |
| FEI numbers | 3014290448 |
| Establishment operations | Manufacturer, Specification Developer |
| 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