Device Description; Indications For Use; Contraindications - Dentsply Sirona SureSmile Mode D'emploi

Device Description

SureSmile® Aligners are fabricated from clear thin thermoformed
plastic in a sequential series to reposition the teeth progressively.
Minor, incremental changes in tooth positions in each subsequent
aligner deliver corrective forces to straighten the teeth.

Indications for Use

SureSmile® Aligners are indicated for the treatment of tooth
malocclusion in patients with permanent dentition.

Contraindications

SureSmile® Aligners are contraindicated for use in patients with active
periodontal disease.
Warnings
>
• In rare instances, some patients may be allergic to plastic. Patients
with a history of allergic reactions to plastics should not use this
product.
• Do not use damaged or broken aligners, as their parts can be
accidentally swallowed or aspirated, and may be harmful.
Precautions
• The patient may experience tenderness or temporary discomfort at
initial aligner placement and after switching to each new aligner.
• The aligner may initially affect speech and may result in a lisp, usually
disappearing within two weeks.
• The patient may experience a temporary increase in salivation or
dryness of mouth.
• The aligners may scratch or irritate the patient's lips, cheeks or gums.
• The patient should not wear aligners when drinking hot, sweet, or
colored liquids.
• If patient does not brush and floss correctly during treatment, or if
they consume sugary foods or beverages while wearing aligners,
they may be subject to tooth decay, periodontal disease and
permanent markings from decalcification and staining.
• Lack of compliance in wearing the aligners for the prescribed
number of hours per day or not using the aligners as directed can
increase treatment time and affect desired results.
• The patient's teeth may shift position after treatment. To help
prevent this, the patient should wear retainers.
EN-02
OC-500543_Patient_DFU_ALL_r13_4x7.25.indd 2 10/10/18 9:02 A