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Evenly Technologies, Inc.

Evenly Clear Aligners Instructions for Use

November 2019

Indications for Use

Evenly Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Device Description

Evenly Clear Aligners are custom-made clear plastic trays which when worn in a sequential series, will reposition your teeth. Small, incremental changes in tooth position for each stage of treatment deliver corrective forces to reposition teeth.

Caution: Federal law restricts this device to sale by or on the order of a dentist.

Contraindication

Evenly Clear Aligners are contraindicated for use in patients with the following condition:
• Active periodontal disease.

Warnings

• Rarely, patients may be allergic to plastic. Patients with a history of plastic allergies should not use this product.
• Damaged or broken aligners should not be used as small pieces of plastic can be swallowed or aspirated.

Precautions

• Aligners are intended to only be removed for eating, drinking, and for oral care. Unnecessary and excessive removal and insertion of aligners may prematurely damage and/or break the aligners.

• 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 atone 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 (es, 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. 

• 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.

• 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 the tooth 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.

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

Directions for Use

• Upon receipt of aligners, open bag and rinse well with soap and water before putting into mouth.

• Snap the aligners onto your teeth, making sure to put the upper arch aligner on your upper teeth, and lower arch aligner on your lower teeth.

• To remove your aligners, use your fingers to grasp the aligner edge and gently pull away from your teeth. If resistance is felt, it may be necessary to repeat the previous step in several locations. Do not bend, twist, or use excessive force when removing aligners or they may distort or be damaged. Do not use sharp objects to remove your aligners.

• Wear aligners for at least 22 hours every day during treatment.

• It is normal for new aligners to fit tightly and apply pressure to your teeth. This pressure should lessen the longer you wear each step.

• Contact your doctor or office who supplied treatment if you experience any fitting issues or severe pain.

• Remove the aligners to eat. Brush and floss after every meal to prevent food and drink from getting trapped under the aligner. Do not chew gum while wearing your aligners.

• While wearing your aligners you may experience dry mouth. Drink plenty of water.

• After removing your aligners, make sure to clean them with a toothbrush and cool water.

• When directed by your doctor, advance to the next step.

• Make sure to bring your previous set of aligners with you to any checkups.

• If you lose an aligner, do not use another one and contact your doctor immediately for assistance.

• Dispose of used and completed aligners in household garbage. Aligners are for one-time use only and should not be re-used after advancing to the next stage.

• When removed, store your aligners in the provided carrying case.

• Store your upcoming aligners in their original packaging, in a cool, dry place.

RX Only

If you suspect an adverse reaction, discontinue use immediately and consult your doctor. Your doctor, not Evenly Technologies, Inc., is responsible for managing your orthodontic treatment.

Symbols Glossary

ANSI/AAMI/ ISO 15223-1:2012 Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements.

Symbol Title of Symbol (Reference Number)
Consult Instructions for Use (5.4.3)
Caution: Consult accompanying documents (5.4.4)
Non-sterile device.
Consult Instructions for Use (5.4.3)
Rx Only Caution: Consult accompanying documents (5.4.4)
Non-sterile device.

Evenly Technologies, Inc.
7402 Fairfax Road
Bethesda, MD 20814

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