OrthoPulse 2.0 and 2.1 Feasibility Evaluation

Inclusion Criteria:

- Written Informed Consent must be obtained before any assessment is performed

- Patient must be 11 years of age or older; minors will only be included in the study
with the consent of the Parent/Legal Authorized Representative (LAR)

- Presence of permanent dentition

- Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign

- Good oral hygiene

- Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear

- Have a compatible iOS or Android device and are willing to download the OrthoPulse app
for frequent automatic syncing of use data

Exclusion Criteria:

- Patient is currently enrolled in another clinical study

- Periodontally involved teeth, acute oral infection or periodontal disease

- Use of bisphosphonates (osteoporosis drugs) during the study

- Use of drugs that may cause photosensitivity

- History of photosensitivity

- History of poor oral hygiene, per the discretion of the Principal Investigator (PI)

- Epilepsy

- Patient plans to relocate over the treatment period

- Smoker or use of any tobacco containing products per the discretion of the PI