ELO · Cusp, Gold And Stainless Steel
Dental · 21 CFR 872.3350 · Class 1
Overview
| Product Code | ELO |
|---|---|
| Device Name | Cusp, Gold And Stainless Steel |
| Regulation | 21 CFR 872.3350 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group or stainless steel intended to provide a permanent cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) between the teeth and a removable denture.
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.
