Clinical Research Directory

Inclusion Criteria: 1. Participant has radiographic evidence of at least one mandibular 3rd molar tooth bud between 4 and 8 mm in largest diameter, which typically presents in children between 8 and 12 years of age, and 2. Participant is free from any clinically significant health or behavioral problems that the investigator determines will be inappropriate for inclusion in the Study, and 3. Participant has normal facial and oral anatomy and is free from any abnormality or condition which may impact the performance of the procedure, and 4. Participant's parent or legal guardian is willing and able to sign the approved Informed Consent Form ("ICF") and the Participant will agree with the Participant Assent Form and the Participant is willing and able to provide age-appropriate assent and comply with required study procedures and follow-up. Exclusion Criteria: 1. Participant where use of local anesthetic is contraindicated, or 2. Participant has any behavioral or medical condition which, in the opinion of the Investigator, would prevent adequate performance of the procedure or affect the health and/or safety of the Participant, or 3. Participants with orthodontics (traditional braces or clear aligners), or 4. Participant is immunocompromised, has a history of or potential for bone tissue defects, or has any known sensitivities to anesthetic agents, or Exclusion Post Radiological Exam (by Sponsor) from review of the LL8/#17 and LR8/#32 tooth buds 5. Adjacent 2nd molar has incomplete enamel formation, or 6. Tooth bud has enamel formation (calcification) visible on radiographs, or 7. Tooth bud has a diameter of less than 4 mm or greater than 8 mm, or 8. Tooth bud has less than 3 mm separation from the inferior alveolar nerve canal.