WEARING AND USING YOUR ORMCO SPARK ALIGNERS 

To ensure proper use of your aligners, always:

1. Rinse your aligners in water when removing them from the packaging. 

2. Wear your aligners according to your treating clinician’s instructions, usually 20-22 hours per day. 

3. Each aligner should be worn for 1 to 2 weeks, as instructed by your treating clinician. 

4. If for any reason an aligner stops fitting, contact your treating clinician immediately. 

5. If an aligner is lost or damaged, contact your treating clinician immediately. 

6. Do not discard previously worn aligners. 

7. Handle your aligners with clean, freshly washed, hands. 

ALIGNER INSERTION 

1. To help you ensure that you have the proper aligner, each one is marked with your unique case number, along with an aligner code…(U) for your upper teeth & (L) for your lower teeth, followed by the stage number. (e.g. U7) 

2. Insert your aligners, one at a time. Begin by gently pushing the aligner over your front teeth, followed by pressing on the tops of your back teeth (left & right molars) until the aligner s naps into place. 

3. To avoid damaging your aligners, do not bite your aligners into place.

NOTE: If you experience sharp pain or significant discomfort, discontinue the use of your aligners and contact your treating clinician immediately.

ALIGNER REMOVAL 

1. On one side of your mouth, use your fingertip on the inside of your back
molar to gently separate the aligner from the tooth.

2. Repeat step 1 on the other side of the mouth. 

3. Once aligner is released from the molars on both sides of your mouth, gently begin to separate the aligner from your teeth as you work your way
forward.

REMOVAL TIPS:
• Upon removal, immediately rinse each aligner with water and shake off any excess before storing. 

• To prevent damaging aligners, avoid unnecessary removal. 

• Do not use excessive force that could bend or twist an aligner when removing, using care to avoid stretching or breaking your aligners. 

• Do not use sharp objects to remove your aligners, as this could damage your aligners and/or cause injury to your teeth or gums. 

• Consult with your treating clinician if your aligners are extremely difficult to remove.

 USE AND CARE OF ALIGNERS:

 1. Aligners should be cleaned prior to each insertion using a soft bristle toothbrush with water and a small amount of toothpaste, followed by a thorough rinse with water. If desired, you could clean the outside of the aligners while wearing them, then remove the aligners to clean the inside surfaces.

 2. Do not use denture cleaners to clean aligners; do not soak aligners in mouthwash; do not use hot water, alcohol, or bleach solutions, as these products can damage the surface of the aligner, causing it to become less clear and therefore more visible.

 DAILY ORAL HYGIENE:

 1. Aligners must be removed for eating.

 2. Aligners must be removed for drinking anything but cool water.

 3. Brush and floss your teeth after each meal or snack prior to re-inserting your aligners. If no access to a toothbrush is available, rinse mouth and aligners with water. Aligners should then be thoroughly cleaned at your earliest convenience. 

4. Consult with your treating clinician if you have any questions regarding hygiene techniques.

 5. Regular dental checkups and cleaning are recommended for the continued health of your teeth and gums.

 STORING YOUR ALIGNERS: 

1. Keep all of your aligners in their original packaging or as instructed by your treating clinician. 

2. When not in use, store your aligners in their original packaging or in a suitable container to protect them and keep them clean.

 3. If your current aligner is lost or damaged, your treating clinician may recommend that you temporarily go back to the last aligner that you wore.

 4. Keep aligners out of the reach of small children and pets.

 NOTE: If you have additional questions after reading this Aligner Use and Care Guide, please consult with your treating clinician.

CUSTOM-MADE DEVICE DESCRIPTION 

 The Ormco™ Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the patient’s teeth in small increments from their original state to a more optimal, treated state. 

INDICATIONS FOR USE 

 The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

CONTRAINDICATIONS
 • If patient has active periodontal disease, treatment with clear aligners should be avoided or delayed until patient is free from symptoms of active periodontal disease.

WARNINGS
• In rare instances, some patients may be allergic to the plastic aligner material.
• In rare instances patients with hereditary angioedema (HAE), a genetic disorder, may experience rapid local swelling of subcutaneous tissues including the larynx. HAE may be triggered by mild stimuli including dental procedures.
• In both cases, discontinue use and consult a health care professional immediately. Ormco must also be notified.
• Orthodontic appliances, or parts thereof, may be accidently swallowed or aspirated, which may be harmful.

PRECAUTIONS
• Keep aligners away from hot water and harsh chemicals.
• Keep aligners out of reach of young children and pets.
• Always store aligners in a cool, dry place.
• Treatment of severe open bite, severe overjet, mixed dentition, and/ or skeletally narrow jaw may require supplemental treatment in addition to aligner treatment.

• Skeletal expanders, bonded auxiliaries, elastics, and other fixed and/or removable orthodontic appliances, may be needed for more complicated treatment plans where aligners alone may not be adequate to achieve the desired outcome.
• Oral surgery may be necessary to correct severe crowding or jaw imbalances. If oral surgery is required, risks associated with anesthesia and proper healing must be taken into account prior to treatment. 

• Atypically-shaped, erupting, and/or missing teeth may affect aligner

adaptation and may affect the ability to achieve the desired results. 

• Existing dental restorations (e.g., crowns, bridges) may become dislodged and require re-cementation or, in some instances, replacement. 

• Aligners are not effective in the movement of dental implants. 

• Certain medical conditions and use of certain medications may affect orthodontic treatment outcomes. 

• Dental tenderness may be experienced following initial aligner placement and after switching to each new aligner in the series. 

• The product may temporarily affect speech and may result in a lisp, although any speech impediment associated with the product usually disappears within one or two weeks. 

• Failure to wear the appliances for the prescribed number of hours per day and/or not using the product as directed by your doctor can lengthen the treatment time and affect the ability to achieve the desired results. 

• Gums, cheeks, or lips may be scratched or irritated by the product. 

• Attachments may be temporarily bonded to one or more teeth during the course of treatment to facilitate aligner retention and/or tooth movement. 

• Attachments may fall off and require replacement.
• All attachments should be removed upon completion of treatment. 

• Risks associated with interproximal reduction, which may be prescribed to create space for tooth movement as part of treatment must be taken into account. 

• Tooth decay, periodontal disease, and permanent markings from stains and decalcification may occur if patients do not brush and floss their teeth properly during treatment or if they consume foods or beverages containing sugar while wearing aligners. 

• The bite may change throughout the course of treatment and may result in temporary patient discomfort. 

• At the end of treatment, the bite may require adjustment by the doctor. 

• Teeth may shift position after treatment. Consistent wearing of retainers at the end of treatment should reduce this tendency. 

• It is recommended that all teeth should be at least partially covered to help prevent supra-eruption. 

• Temporary increase in salivation or dryness of mouth may occur.
• A tooth that has been previously traumatized or significantly
restored may be aggravated. In rare instances, the useful life of thetooth may be reduced, the tooth may require additional dental treatment such as endodontic and/or additional restorative work, and/or the tooth may be lost. 

• The health of the bone and gums which support the teeth may be impaired or aggravated. 

• The length of the roots of the teeth may be shortened during orthodontic treatment, which may become a threat to the longevity of the teeth. 

• In rare instances, problems in the temporo-mandibular joint (jaw joint) may result in joint pain, headaches, or ear problems. 

 WARNING:
In rare instances, some patients may be allergic to the plastic aligner material. If adverse reaction occurs (allergic or otherwise), discontinue use and seek immediate medical attention; Ormco must also be notified.
WARNING:
Orthodontic appliances may be accidently swallowed or aspirated, which may be harmful.
USER AND PATIENT NOTICE:
If a serious incident occurs with this medical device, report it to the manufacturer and to the competent medical authority for the user/patient’s country.

 — Updated from Spark /Ormco