U.S. FDA Medical Device Dental Amalgamator Requirements
FDA Medical Device Definition: A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.
FDA Dental Amalgamator Label Requirements and Exceptions
FDA Dental Amalgamator Import Information
FDA Dental Amalgamator Detentions (Dental Amalgamator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Dental Amalgamator Manufacturers (Dental Amalgamator Suppliers)
- Dental Amalgamator Distributors
- Dental Amalgamator Processors
- Dental Amalgamator Repackers
- Dental Amalgamator Relabelers
- Dental Amalgamator Exporters
- Dental Amalgamator Importers
For more information about Dental Amalgamator 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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