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U.S. FDA Medical Device Wire Clasp Requirements

FDA Medical Device Definition: A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth. Wire_Cutter=An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Registrar Corp assists Wire Clasp companies with:

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