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U.S. FDA Medical Device Rubber Dam Frame 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 Frame companies with:

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