U.S. FDA Medical Device Preformed Anchor Requirements
FDA Medical Device Definition: A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.
FDA Preformed Anchor Label Requirements and Exceptions
FDA Preformed Anchor Import Information
FDA Preformed Anchor Detentions (Preformed Anchor Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Preformed Anchor Manufacturers (Preformed Anchor Suppliers)
- Preformed Anchor Distributors
- Preformed Anchor Processors
- Preformed Anchor Repackers
- Preformed Anchor Relabelers
- Preformed Anchor Exporters
- Preformed Anchor Importers
For more information about Preformed Anchor 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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