Product code
PEM: Dental barriers and sleeves
FDA product code · Class II · Dental
Key facts
| Product code | PEM |
|---|---|
| Device | Dental barriers and sleeves |
| Device class | Class II |
| Regulation number | 878.4370 |
| Review panel | Dental |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- None 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