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

FDA Medical Device Definition: A dental electrosurgical unit and accessories 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 and Accessories companies with:

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