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

For Professional Use Only – Rx Only

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.
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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 for Doctors
• Do not sterilize SureSmile® Aligners.
• When evaluating the use of interproximal reduction to create space
for tooth movement, you should consider all associated risks.
• Treatment with SureSmile® Aligners is an orthodontic therapy and
you should consider all potential side effects associated with such
therapy.
• The health of the bone and gums supporting the teeth may be
adversely affected.
• Certain medical conditions or medications can affect orthodontic
treatment outcomes.
• Orthodontic treatment may shorten the teeth roots. This may
reduce the longevity of the teeth.
• Missing, erupting or unusually shaped teeth may affect treatment
outcomes.
• To help prevent supra-eruption, the aligner should cover all teeth.
• Existing dental restorations such as crowns or bridges, may
require recementation or, in some cases, replacement.
• Aligners are not effective for moving dental implants.
• You may need to use skeletal expanders, bonded auxiliaries,
elastics and other fixed and/or removable orthodontic appliances
for more complicated treatment plans where aligners alone may
not be adequate to achieve the desired outcome.
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