Product code
ORY: Tongue suspension system
FDA product code · Class II · Dental
Key facts
| Product code | ORY |
|---|---|
| Device | Tongue suspension system |
| Device class | Class II |
| Regulation number | 872.5570 |
| Review panel | Dental |
| Medical specialty | Dental |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database