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U.S. FDA Medical Device Gold & Stainless Steel Cusp Requirements


FDA Medical Device Definition: A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group or stainless steel intended to provide a permanent cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) between the teeth and a removable denture.

Registrar Corp assists Gold & Stainless Steel Cusp companies with:

  • FDA Gold & Stainless Steel Cusp Establishment Registration
  • FDA Gold & Stainless Steel Cusp Listing
  • FDA Gold & Stainless Steel Cusp Label Requirements and Exceptions
  • FDA Gold & Stainless Steel Cusp Import Information
  • FDA Gold & Stainless Steel Cusp Detentions (Gold & Stainless Steel Cusp Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Gold & Stainless Steel Cusp Manufacturers (Gold & Stainless Steel Cusp Suppliers)
       - Gold & Stainless Steel Cusp Distributors
       - Gold & Stainless Steel Cusp Processors
       - Gold & Stainless Steel Cusp Repackers
       - Gold & Stainless Steel Cusp Relabelers
       - Gold & Stainless Steel Cusp Exporters
       - Gold & Stainless Steel Cusp Importers
For more information about Gold & Stainless Steel Cusp Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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