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U.S. FDA Medical Device Dental Hand Instruments 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 Dental Hand Instruments companies with:

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