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U.S. FDA Medical Device Dental Diamond Instrument Requirements


FDA Medical Device Definition: A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.

Registrar Corp assists Dental Diamond Instrument companies with:

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