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U.S. FDA Medical Device Dental Electrosurgical Unit Requirements: Dental Electrosurgical Unit

FDA Medical Device Definition: A dental electrosurgical unit is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue

Registrar Corp assists Dental Electrosurgical Unit companies with:

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




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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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