Product code
NSR: Prosthesis, orthodontic
FDA product code · Not Classified · Dental
Key facts
| Product code | NSR |
|---|---|
| Device | Prosthesis, orthodontic |
| Device class | Not Classified |
| Review panel | Dental |
| Submission type | Enforcement Discretion |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 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