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U.S. FDA Medical Device Dental Needle Requirements

FDA Medical Device Definition: A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local anesthetics and other drugs.

Registrar Corp assists Dental Needle companies with:

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