Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Orthodontic Elastic Band Regulations

U.S. FDA Medical Device Orthodontic Elastic Band Requirements


FDA Medical Device Definition: An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

Registrar Corp assists Orthodontic Elastic Band companies with:

  • FDA Orthodontic Elastic Band Establishment Registration
  • FDA Orthodontic Elastic Band Listing
  • FDA Orthodontic Elastic Band Label Requirements and Exceptions
  • FDA Orthodontic Elastic Band Import Information
  • FDA Orthodontic Elastic Band Detentions (Orthodontic Elastic Band Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Orthodontic Elastic Band Manufacturers (Orthodontic Elastic Band Suppliers)
       - Orthodontic Elastic Band Distributors
       - Orthodontic Elastic Band Processors
       - Orthodontic Elastic Band Repackers
       - Orthodontic Elastic Band Relabelers
       - Orthodontic Elastic Band Exporters
       - Orthodontic Elastic Band Importers
For more information about Orthodontic Elastic Band 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco