EHQ · Cusp, Preformed
Dental · 21 CFR 872.3360 · Class 1
Overview
| Product Code | EHQ |
|---|---|
| Device Name | Cusp, Preformed |
| Regulation | 21 CFR 872.3360 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A performed cusp is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be used as a temporary cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) before permanent restoration of a tooth.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
