U.S. FDA Medical Device Preformed Clasp 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 Clasp Label Requirements and Exceptions
FDA Preformed Clasp Import Information
FDA Preformed Clasp Detentions (Preformed Clasp Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Preformed Clasp Manufacturers (Preformed Clasp Suppliers)
- Preformed Clasp Distributors
- Preformed Clasp Processors
- Preformed Clasp Repackers
- Preformed Clasp Relabelers
- Preformed Clasp Exporters
- Preformed Clasp Importers
For more information about Preformed Clasp 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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