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U.S. FDA Medical Device Orthodontic Band Setter 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 Orthodontic Band Setter companies with:

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