FDA 510K Submission - Dental Aligner - Clear Aligner

Dental aligners are orthodontic devices that are used to straighten teeth and correct malocclusions. Sequential dental aligners, also known as clear aligners, are a popular type of dental aligner that use a series of clear plastic trays to gradually shift the teeth into their correct position.

Each aligner in the sequence is custom-made for the patient's specific orthodontic needs, based on digital models of their teeth. The aligners are typically worn for about two weeks before being replaced with the next one in the sequence, with each aligner slightly different than the one before it, in order to gradually shift the teeth into the desired position.

Sequential dental aligners are a popular alternative to traditional braces, as they are virtually invisible, removable, and do not require any wires or brackets. They are often preferred by adults and teenagers who want to straighten their teeth without the stigma associated with traditional metal braces. However, it is important to note that sequential dental aligners are not suitable for all orthodontic cases, and only a qualified orthodontist can determine whether they are the right treatment option for a particular patient.

FDA Classification for Dental Aligner

Regulation Number

Dental Aligner Code

Dental Aligner Class

Dental Aligner Type



Class 2

Aligner, Sequential



Class 1
510(K) Exempt

Aligner, Bracket, Orthodontic



Class 1
510(K) Exempt

Aligner, Beam, X-Ray

FDA 510K Clearance for Dental aligners are public information; you can search for it on the FDA website. Please click here for an example.

LMG Provides assistance to dental aligner manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare 510k notification
  • Submission of 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your dental establishment with FDA
  • List your dental aligner with FDA.

Test Requirements for Dental Aligner for US FDA 510K Submission

US FDA 510K Submission Requirements

FDA 510K Consultant