A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.

Inclusion Criteria:

• Subject willing to participate in the clinical investigation, able to understand theintent risks and benefits of the clinical investigation as well as associated timecommitment and follow-ups visits.

• Subject has signed and dated the informed consent form (ICF) .

• Subject aged 18 years or above at time of informed consent.

• Subject has permanent dentition (i.e., all 2nd molars).

• Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexityand within the clinical references as defined in the SureSmile Case Selection Guide.

• Crowding or spacing must be ≤6mm present in one or both arches consistent withlevel 1 and 2 of case complexity.

• Midline deviation must be ≤3 mm consistent with level 1 and 2 of casecomplexity.

• Overjet must be ≤4 mm consistent with level 1 and 2 case complexity.

≤3 mm consistent with level 1 and 2 case complexity.

• Anterior open bite must be ≤1 mm, consistent with level 1 and 2 casecomplexity.

• Intermaxillary elastics may be included within the treatment plan to supportsagittal, vertical, or transverse correction within the limits defined underexclusion criteria.

Exclusion Criteria:

• Subjects unlikely to comply with investigational procedures, or unlikely to comeback for follow-up visits, as judged by the Investigator.

• Subject that presents a dental malocclusion classified as level 3 case complexity,as defined in the SureSmile Case Selection Guide.

• Subjects who have completed aligner therapy within the last 12 months or who are inactive orthodontic treatment.

• Subjects with active periodontal disease or other unresolved dental conditions suchas active cavities, active periodontal disease.

• Subjects with treatment plans requiring transverse correction requiring expansiongreater than 4 mm per arch or 2 mm per quadrant, or any skeletal transversecorrection.

• Treatment plans requiring sagittal correction exceeding a half-cusp discrepancy (i.e., >½ unit) in molar or canine relationships.

• Subjects with treatment plans require vertical correction beyond Level 1 and 2thresholds (i.e., overbite >3 mm or anterior/posterior open bite >1 mm), or verticalelastics exceeding 3 mm.

• TMJ (Temporo-Mandibular Join) disorders or history of headaches or migraines.

• Participants with known history of plastic allergies.

• Subjects with presence of skeletal discrepancies necessitating orthognathic surgery,rapid palatal expansion, other orthopedic intervention, unilateral or bilateralcross-bites, mandibular deviations in association with the diagnosed malocclusion

• The use of TADs (Temporary Anchor Devices), plates, other fixed anchorageancillaries or the use of functional appliances (distalizers, growth modificationdevices), any approach involving orthopedic or skeletal sagittal correction or theuse of hybrid fixed appliances are not considered part of the scope of this clinicalinvestigation and these subjects are not eligible.

• Uncontrolled para-functional habits, e.g., bruxism.

• Any other condition that would make the subject unsuitable for participation,including but not limited to:

• Unstable psychiatric illness.

• Recent myocardial infarction (< 3 months*).

• Recent cerebrovascular accident (< 3 months*).

• Recent cardiac-valvular prosthesis placement (< 3 months*).

• Hemorrhagic diathesis.

• Severe liver dysfunction.

• Known or suspected current malignancy.

• Known pregnancy at the time of enrolment.

• Previous enrolment in the present clinical investigation.

• Involvement in the planning and conduct of the clinical investigation (applies toboth Dentsply Sirona personnel and the clinical investigation site).

• Participation in another clinical investigation that may interfere with the presentclinical investigation.