Blue Sky Plan Manual

Indications for Use: Blue Sky Bio Aligner G is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars), utilizing incremental tooth movements to sequentially position teeth by continuous gentle force. Contraindication: contraindicated for patients allergic to plastics.

Device Description: Blue Sky Bio Aligner G is 3D printed using Tera Harz Clear (P/N TC-85DAC) photo-curable resin by Graphy Inc., designed with the Blue Sky Plan software module for Blue Sky Bio Aligner G. A dental clinician assesses the patient's teeth and determines the course of treatment, takes molds (or scans the mouth directly with an intraoral scanner), and the STL files are uploaded into Blue Sky Plan software. The dental lab or clinician designs a series of digital models and sequential aligners in the software; the prescribing physician reviews and approves the model scheme before production. Blue Sky Bio or its authorized lab then 3D prints and post-cures the sequential Tera Harz Clear aligners, cleans and polishes them, and delivers them to the clinician. Each aligner is worn for approximately 1-2 weeks, 20-22 hours per day (removed for eating and cleaning), before being replaced by the next stage.

Scanning and Design: The clinician takes molds or scans the patient's mouth directly to obtain baseline dentition STL files. The dentist (or a dental technician, subject to the licensed dentist's review and approval) then uses the Blue Sky Plan software module for Blue Sky Bio Aligner G to develop the treatment plan and produce standard STL files for each sequential aligner. Caution: the dentist should provide the patient with only a few sets of aligners at a time and must monitor progress periodically before delivering subsequent aligners.

Printing Process: Use a SprintRay Pro 95 3D printer to print each treatment step's aligners from the STL files (each under 500 MB). Parametric settings: Material Mode SPRINTRAY SPLINT Layer; Resin Curing Wavelength 405 nm LED; Layer Thickness 100 μm; Exposure Time 2 seconds; recommended orientation 30° from the platform; Support function Auto; Printing Position all positions with 5 mm offset; environmental conditions 15-25°C and 30-75% relative humidity. Uncured resin (leftover resin) may be reused up to 6 times; discard after 7 uses. Required resin volume for 7 fabrication cycles on the Pro 95 is 310 g; one aligner set (upper and lower) requires 35 g; minimum replenishment volume is 100 g. Never pour leftover resin back into the original bottle, and never mix new and leftover resin.

Printing Preparation and 3D Printing: Shake the Tera Harz Clear resin vigorously in its original packaging before use, and always clean the resin tank of any impurity or residual resin/alcohol before printing. Wear protective glasses and gloves when handling resin and printed parts. Pour resin into the printer's tank up to the filling line and close the printer cover. Load the digital aligner STL file, set the optimal build position at 30 degrees from the platform, generate lingual supports per the manufacturer's recommendation (adding more if needed), and start printing.

Cleaning Residual Resin: Detach the printed aligner from the build platform and remove supports. Place the aligner on a paper towel, inner surface facing down, and let it stand for 1 hour until residual resin is removed. Wipe off any remaining residual resin with a cotton swab. Safely dispose of any leftover uncured resin in the tank rather than reusing or mixing it with new resin.

Post-processing: The printed aligner must undergo post UV curing and a nitrogen process using a CureM U102H UV Cure Oven only (Lamp Power 80 W, Light Intensity 400 mW/cm², Lamp Wavelength 395-405 nm). Place the aligner on the CureM plate, connect the nitrogen generator tube, place the plate in the curing unit, add nitrogen at 10 L/m for 1 minute, then cure for 30 minutes, turn the aligner over, and cure for another 30 minutes under the same nitrogen conditions (60 minutes total). Remove the aligner with tongs once curing is complete, and polish with wet sandpaper if necessary.

Cleaning and Finishing: Wash the aligner in warm water, place it on a tissue and let it stand for 30 minutes until dry, then check the surface and finish the process.

Labeling and Packaging: Prior to sending aligners to the clinician, the dental lab places each aligner in a labeled plastic bag showing the patient name and identifier number, doctor's name, dental lab contact information, Rx symbol, aligner step number, and the Patient Instruction for Use.

Warnings: Tera Harz Clear contains polymerizable monomers which may cause skin irritation or allergic reactions in susceptible persons – wash thoroughly with soap and water on skin contact and discontinue use if sensitization occurs. Avoid inhalation or ingestion; high vapor concentration can cause headache and irritation of eyes or the respiratory system, and direct eye contact may cause corneal damage. Tera Harz Clear should be used only for orthodontic appliances as validated. Wear protective glasses and nitrile gloves whenever handling the resin, work in a well-ventilated area, and fully cure any resin before disposal. Store Tera Harz Clear in its original packaging at room temperature (15-25°C) in a dry, dark area, and do not use past its expiry date.

Explanation of Symbols used on packaging and labeling:

Blue Sky Bio, LLC – 800 Liberty Drive, Libertyville, IL 60048 – info@blueskybio.com – (888) 446-6724