Device Description; 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.
SureSmile® Retainers are fabricated from clear thin thermoformed
plastic designed to hold teeth in place.
Indications for Use
SureSmile® Aligners are indicated for the treatment of tooth
malocclusion in patients with permanent dentition.
Intended Use/Performance Characteristics
SureSmile® Aligners are intended to align teeth into position for
the treatment of tooth malocclusion in patients with permanent
dentition as prescribed by your doctor.
SureSmile® Retainers are intended for use in retention and the
prevention of relapse at the completion of orthodontic treatment.
Clinical Benefits
Clinical benefits of orthodontic treatment include overall
improvement of tooth health and correction of malocclusion.

Contraindications

SureSmile® Aligners and Retainers are contraindicated for use in
patients with active periodontal disease.
Warnings
• In rare instances, some patients may be allergic to plastic. If you
have a history of allergic reactions to plastics you should not
use this product. If an allergic reaction occurs while wearing
your aligners or retainers, discontinue use and consult your
doctor immediately.
• Do not use damaged or broken aligners or retainers, as their
parts can be accidentally swallowed or aspirated, and may be
harmful.
• If your aligners, retainers or an attachment is lost or broken,
immediately contact your doctor.
• Call your doctor immediately if you lose or break your retainers.
Too much time without retainers will allow your teeth to move.
• Report serious incidents that have occurred in relation to the
device to device manufacturer and the Competent Authority
in Member State of residence, or other applicable regulatory
agency.
Precautions
• Do not chew gum, candy, or ice while wearing the device.
• You may experience tenderness or temporary discomfort at
initial aligner or retainer placement and after switching to each
new aligner.
• The aligner and retainer may initially affect speech and may
result in a lisp, usually disappearing within two weeks.
• You may experience a temporary increase in salivation or
dryness of mouth.
• The aligners and retainers may scratch or irritate your lips,
cheeks or gums. If this occurs, contact your doctor.
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• Lack of compliance in wearing the aligners and retainers for
the prescribed number of hours per day or not using them as
directed can increase treatment time and affect desired results.
• Your teeth may shift position after aligner treatment. To help
prevent this, you should wear retainers.
• If your aligner and retainer are not fitting well in your mouth, it
may need to be adjusted. Contact your doctor.
Adverse Reactions
Allergic reactions, to plastics.
How-To Instructions
Cleaning Your Aligners/Retainers
Clean your aligners and retainers before you insert them.
• Use the dental appliance cleaner recommended by your doctor.
Be sure to follow the instructions of the dental appliance
cleaner. Retainer Brite® products are recommended to clean
your SureSmile® aligners and retainers.
• You may use a soft bristle toothbrush and water. You should
NOT use toothpaste or soak your aligners and retainers in
mouthwash as this can scratch or dull the plastic, adversely
affecting the clarity. Do NOT use denture cleaners.
• Rinse each aligner and retainer thoroughly with water after
each cleaning. Shake off excess water and then store your
aligners and retainers in a protective case.
Inserting Your Aligners and Retainers
• Wear your aligners per your doctor's instructions, usually 20-22
hours daily (includes sleeping).
• Wear your retainers as indicated by your doctor. Not wearing
your retainers as prescribed may allow your teeth to move back
into the old position.
• Handle your aligners and retainers with care. Handle ONE
aligner or retainer at a time when inserting, removing or
cleaning.
• Wash your hands thoroughly with soap and water before
handling your aligners and retainers.
• Clean your aligners and retainers before you insert them.
• Make sure you have the correct
stage aligner. Each aligner and
retainer is engraved with the
first four letters of your name, a
"U" for upper teeth or an "L" for
lower teeth, followed by the stage
number or RET for retainers.
• Insert only one aligner or retainer
at a time. Trying to seat two at
once, or using excessive pressure, may damage the device.
• You may insert either the upper or the lower aligner or retainer
first. When inserting each aligner or retainer, gently push it over
your front teeth. Next, apply equal pressure with your fingertips
to the tops of your left and right molars (big teeth at the back)
until the aligner or retainer snaps into place.
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