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FDA Regulations Involving Orthodontic Aligners (Regulatory Standards CE)

Tim Torbenson

June 2021 Issue - Expires Tuesday, December 31st, 2024

Inside Dental Technology


Manufacturers continue to develop more accessible products and workflows to encourage more dental laboratories to add orthodontic aligners to their offerings. Any laboratory doing so, however, should be well-versed on the FDA requirements for fabricating these appliances. This article covers all options for laboratories seeking to enter into this market space.

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SOURCE: Inside Dental Technology | June 2021

Learning Objectives:

  • Discuss the FDA requirements for manufacturing orthodontic aligners.
  • Explore the various options for laboratories to offer orthodontic aligner services.
  • Describe in simple terms what a Quality System is and what it entails.


The author reports no conflicts of interest associated with this work.

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