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Hi All,
I have a finished device (dental material) that will be further processed in a country that has no regulatory requirements for the device.
The device has a 510(k). The 510(k) submission was for a slightly different material composition. The components of the material are identical with a slight change in a trace element (component). The existing risk analysis used for the 510(k) is applicable, the bio compatibility test reports for the original material are applicable, and the material has properties that are so similar to the original material, it could be considered identical to the properties of the material listed on the 510(k).
Can I export this material to a country with no regulatory requirements with the same product name, labeling, etc... as the product listed with the FDA? Other?
Thanks for any advice.