U.S. FDA Medical Device Preformed Cusp Requirements
FDA Medical Device Definition: 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.
FDA Preformed Cusp Label Requirements and Exceptions
FDA Preformed Cusp Import Information
FDA Preformed Cusp Detentions (Preformed Cusp Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Preformed Cusp Manufacturers (Preformed Cusp Suppliers)
- Preformed Cusp Distributors
- Preformed Cusp Processors
- Preformed Cusp Repackers
- Preformed Cusp Relabelers
- Preformed Cusp Exporters
- Preformed Cusp Importers
For more information about Preformed Cusp Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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