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U.S. FDA Medical Device Silicate Protector Requirements

FDA Medical Device Definition: A silicate protector is a device made of silicone intended to be applied with an absorbent tipped applicator to the surface of a new restoration to exclude temporarily fluids from its surface

Registrar Corp assists Silicate Protector companies with:

  • FDA Silicate Protector Establishment Registration
  • FDA Silicate Protector Listing
  • FDA Silicate Protector Label Requirements and Exceptions
  • FDA Silicate Protector Import Information
  • FDA Silicate Protector Detentions (Silicate Protector Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Silicate Protector Manufacturers (Silicate Protector Suppliers)
       - Silicate Protector Distributors
       - Silicate Protector Processors
       - Silicate Protector Repackers
       - Silicate Protector Relabelers
       - Silicate Protector Exporters
       - Silicate Protector Importers
For more information about Silicate Protector 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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