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Indications for use

The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.

Contraindications

Byte® System is contraindicated for use in adult and adolescent patients presenting the following conditions

• Active periodontal disease

• Severe open bite

• Severe overjet

• Tooth malocclusion requiring surgical correction

• Patients with mixed dentition

• Adolescent patients with a skeletally narrow jaw

• Patients with dental prosthetics/implants

Warnings

• In rare instances, some patients may be allergic to the plastic aligner material. In such cases, discontinue use and consult a health care professional immediately. Byte® must also be notified.

• Orthodontic appliances, or parts thereof, may be accidentally swallowed or aspirated and may be harmful.

• Report serious incidents that have occurred in relation to the device to the manufacturer and to the applicable regulatory agency in the country where the event occurred.

Precautions

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

• Regular dental checkups and cleanings are recommended for the continued health of teeth and gums.

• Not brushing and flossing your teeth properly during treatment may lead to tooth decay, periodontal disease, and permanent markings from stains and decalcification.

• 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 and in the provided carrying case. Don't wrap aligners in a napkin or paper towel.

• Protect aligners from the sun, hot cars, or excessive heat.

• Clean aligners before putting them in each time.

• Brush and floss teeth before putting aligners in.

• Use cold or warm water when cleaning or rinsing aligners.

• Use a soft bristle toothbrush to get a more thorough clean. Rinse with water after cleaning.

• Don't use sharp objects to remove aligners.

• Don't soak aligners in mouthwash or certain denture cleaners since this can damage or discolor them.

• Don't wear aligners while eating or drinking anything other than cool water.

• Don't bite aligners into position. This can damage aligners and teeth.

• Failure to wear the aligners for the recommended amount of time and/or not using the product as directed by these instructions and your doctor can lengthen treatment time and affect the ability to achieve desired results.

See Customer Consent for more information.

Indications for Use

Intended for use by the orthodontic patient during treatment with aligners to facilitate minor anterior (or front) tooth movement.

Contraindications

• Do not use the vibration device if you have Vertigo or Temporomandibular Joint (TMJ) Syndrome to avoid symptoms such as headache, dizziness, and aching facial pain related to these disorders.

• Do not use any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) during the treatment to avoid inhibition of orthodontic tooth movement.

• Do not use the vibration device if you are pregnant.

Warnings

• Use the vibration device only as instructed by Byte or your local dentist. Discontinue use of the device and consult Byte or your local dentist if you experience sensitivity to vibrations or if you experience headache, dizziness, nausea, discomfort or pain.

• Do not make any modification to the vibration device. Any modification may impair functionality of the device.

• The vibration device may not be suitable to use in conjunction with certain dental restorations.

• Consult with Byte or your local dentist before use.

• The vibration device is not recommended for patients diagnosed with periodontal disease.

• Discontinue use of the vibration device if your orthodontic appliance is damaged.

Precautions

• It is important to read the HyperByte Instructions for Use prior to operation for proper use, maintenance and care.

• The device is intended to be re-used.

• Before use, inspect the device and packaging to verify that no damage has occurred as a result of shipping and handling.

• Do not use damaged products.

• Always recharge the device in accordance with the Instructions for Use prior to use.

• Never use device when plugged into power source. Refer to “CHARGING” section.

• Never use any other alternative power sources or instruments in conjunction with the device.

• Do not use the device to clean or brush teeth.

• Use the HyperByte only as instructed by Byte or your local dentist.

• The HyperByte is not waterproof, don’t use near running water or get wet.