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U.S. FDA Medical Device Rubber Dam Requirements

FDA Medical Device Definition: A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in 884.5300 of this chapter.

Registrar Corp assists Rubber Dam companies with:

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