Primer Aligner Study

The Invisalign® System consists of a series of clear plastic aligners that are intended to
replace conventional wire and bracket technology for many orthodontic cases. Each custom
manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their
original state to a final, treated state. Each aligner is worn for about two weeks, then
replaced by the next in the series until the final position is achieved. For years,
orthodontists and dentists have used removable appliances for orthodontic treatment. Today,
with the application of computer technology and custom manufacturing, Invisalign treats a
broader range of cases with greater precision.

Inclusion Criteria:

- Subject must have fully erupted dentition

- Age range ≥18 years old (Adult subject)

- Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets

Exclusion Criteria:

- Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and
3rd molars)

- Subject who has mixed dentition

- Subject with periodontal disease

- Subject with active caries

- Subject with Temporomandibular Joint Disorders symptoms

- Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to
the start of treatment

- Subject has undergone any accelerated orthodontic treatment prior to or during
treatment as part of this study

- Subject has known allergy to latex or plastic

- Subjects who are pregnant or will become pregnant during treatment