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U.S. FDA Medical Device Endodontic Broach Requirements

FDA Medical Device Definition: A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Registrar Corp assists Endodontic Broach companies with:

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