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U.S. FDA Medical Device Oral Irrigation Unit Requirements


FDA Medical Device Definition: An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.

Registrar Corp assists Oral Irrigation Unit companies with:

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