Blue Sky Plan Manual

Rx only. Federal law restricts this device to sale by or on the order of a physician.

Device Description: Blue Sky Bio Aligner G is a sequence of clear plastic, removable, orthodontic aligners that gradually move the patient's permanent teeth in small increments to correct a misalignment. It is indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars), utilizing a series of incremental tooth movements to sequentially position teeth by continuous gentle force. Contraindication: do not use if allergic to plastics.

Warnings and Precautions: Because the aligners are worn in the mouth, accidental swallowing or aspiration may occur and may be harmful. Keep aligners away from hot water and harsh chemical solutions – do not use denture cleaners, and do not drink hot or colored liquids with aligners in place. Keep aligners out of reach of young children and pets. When not in use, store aligners in the container provided. Aligners worn out of sequence can result in delayed treatment and complications including patient discomfort – always follow the doctor's specified order. Sensitivity and tenderness to teeth may occur during treatment, especially when moving from one aligner step to the next. Wearing the aligner may temporarily affect speech; patients typically adapt within a week or two. Irritation of the soft tissue in the mouth may occur – consult your doctor if this persists. Avoid chewing gum when using the aligners. Do not use sharp objects to remove aligners.

Hygiene: Rinse new aligners with cold water prior to first use. Clean aligners prior to each use with a soft-bristle toothbrush and a small amount of toothpaste; do not expose aligners to hot water. Wash hands thoroughly with soap and water before handling aligners. Maintain proper oral hygiene during treatment – brush and floss after each meal prior to inserting aligners, and keep regular dental checkups and cleanings.

Aligner Placement: Aligners are worn according to the doctor's instructions, usually 20-22 hours per day, for the recommended number of days per aligner in sequence. Handle only one aligner at a time. Insert the aligners as marked for upper or lower use (either may be inserted first). When inserting, gently push over the front teeth, then apply pressure with your fingertips to the tops of the left and right molars until the aligner snaps into place.

Aligner Removal: Use your fingertip on the inside of the back molar on one side to slowly pull the aligner from the molars, then repeat on the other side before fully removing it. Once disengaged from the molars, gently pry it away from the teeth with your fingertips. After removal, rinse the aligner with water, shake off excess water, and store it in the case provided. If you have attachments on your teeth, take care not to dislodge them when removing aligners.