Blue Sky Plan Manual

Caution: US federal law restricts this product for sale by or on the order of a dentist or physician.

Indication for Use: Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilising a series of incremental tooth movements, it sequentially positions the teeth by way of continuous gentle force.

Device Description: Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilising a set of removable aligners to correct tooth malocclusions. A dental health professional (e.g. orthodontist or dentist), using a standard personal computer, prescribes the Blue Sky Bio Aligners based on an assessment of the patient's teeth, determines the course of treatment with the system, takes moulds of the patient's teeth and then imports a digital version of the mould (or model) into the ordering software, then in the ordering software aligns the teeth as they want them at different phases of treatment. The phase models are exported from the ordering software and sent to Blue Sky Bio. Blue Sky Bio then prints a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription in the ordering software. The trays are sent back to the dental health professional who then provides them to the patient, confirming their fit and design. Over a period of time, additional trays are provided sequentially to the patient to gradually move the target teeth to the designed position. The trays are held in place by pressure and can be removed by the patient at any time.

Storage and Handling: Store the devices in a dry, clean and dust-free environment in the original packaging at modest temperatures (5°C to 40°C / 41°F to 104°F).

Contents of the Box: The box contains the aligners for the patient identified by the stickers on the plastic bags containing the aligners. These were made from the models sent to Blue Sky Bio. If at any office visit the aligner fits incorrectly, scan the patient, go through the construction/ordering process again and send Blue Sky Bio a new model for aligner re-fabrication. The aligners are delivered clean but NON-STERILE in a plastic bag, with a sticker identifying the patient and aligner number. The patient should be instructed to clean the aligner with toothpaste and a toothbrush each day, brushing teeth before inserting the aligner.