U.S. FDA Medical Device Denture Cleanser Requirements
FDA Medical Device Definition: An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.
FDA Denture Cleanser Label Requirements and Exceptions
FDA Denture Cleanser Import Information
FDA Denture Cleanser Detentions (Denture Cleanser Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Denture Cleanser Manufacturers (Denture Cleanser Suppliers)
- Denture Cleanser Distributors
- Denture Cleanser Processors
- Denture Cleanser Repackers
- Denture Cleanser Relabelers
- Denture Cleanser Exporters
- Denture Cleanser Importers
For more information about Denture Cleanser 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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