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: The Blue Sky Bio Computerised Orthodontic Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct malocclusions in orthodontic patients, for use by dental professionals trained in orthodontic treatment. It is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time. The additive printing of the indirect bonding trays should only occur at a validated printing centre, registered and listed as a contract manufacturer with Blue Sky Bio per the FDA Device Establishment Registration and Listing (CFR Part 807).

Device Description: The device consists of proprietary software that allows the placement of virtual orthodontic brackets on 3D models supplied by the clinician. The physical models are scanned and converted into virtual models in the software. An indirect bonding tray made out of resin is produced, into which the physical orthodontic brackets are inserted; the tray aids in accurate bonding by duplicating the position of the virtual brackets in the planning software. The tray is produced using one of two methods: (1) the virtual model with virtual brackets is used to design and print a negative of the model with cavities for the brackets, printed only in an FDA registered establishment; or (2) a printed patient model with bracket-position markers has brackets glued to it, and an indirect bonding tray is pressure thermoformed over the model, capturing the brackets. Both methods result in a resin indirect bonding tray with brackets attached according to the bracket position planned in the software. The clinician inserts the tray on the patient's dentition for accurate bracket placement and bonding.

User Identification: The clinician creates the patient models to be scanned into the software, and either creates or reviews and approves the virtual orthodontic treatment plan, including bracket positions. The software is intended to be used by Blue Sky Bio and authorised entities manufacturing the indirect bonding tray based on the clinician-approved bracket positioning.

How to use: The dental professional creates and scans a model of the patient's dentition into digital form (or scans a physical impression), and imports it into an activated copy of the Computerised Orthodontic Bracket System. An authorised user (a Blue Sky Bio employee or authorised purchaser) activates the software. Based on the patient's 3D models and treatment plan, the operator identifies ideal bracket placement from the software's database of commercially available brackets; the dental professional reviews, approves, and can adjust the final bracket position.

Use of the Indirect Bonding Tray: IBTs are patient-specific devices for short-term use in the mouth, serving as a placement guide for precise bracket positioning. The clinician verifies the tray's fit on the dentition and that bracket spaces match the virtual treatment plan, then inserts the brackets into the tray with a legally marketed bonding agent and places the tray in the patient's mouth to bond the brackets, following the bonding agent manufacturer's instructions. The clinician can adjust bracket position manually if necessary. The procedure is the same regardless of which manufacturing method produced the tray.