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U.S. FDA Medical Device Dental Implant Accessories Requirements


FDA Medical Device Definition: Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.

Registrar Corp assists Dental Implant Accessories companies with:

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