Direct Printed

Shape Memory Aligner

Manual
 Shape Memory Aligner Manual

Contents

1. INTRODUCTION _______________________________________________________________ 4

2. SAFETY OF SHAPE MEMORY ALIGNER ______________________________________ 6

3. CLINICAL EFFECTIVENESS & PRECISION_____________________________________ 8

4. SLICING _______________________________________________________________________ 11

5. PRINTING ALIGNERS ________________________________________________________ 17

6. DETACHING ALIGNERS FROM THE BUILD PLATE__________________________ 18

7. CENTRIFUGING (REMOVE RESIDUAL RESIN) _______________________________ 19

8. DETACHING SUPPORTS _____________________________________________________ 22

9. CURING (TERA HARZ CURE 2) ______________________________________________ 24

10. POLISHING ___________________________________________________________________ 28

11. WASHING, BOILING & DRYING _____________________________________________ 30

12. PACKING & DELIVERY _______________________________________________________ 33

13. PRECAUTIONS ________________________________________________________________ 34

14. CLINICAL ISSUES WITH GRAPHY SHAPE MEMORY ALIGNER _____________ 36

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 Shape Memory Aligner Manual

The Graphy TC-85DAC is classified as a

medical device, meaning that adherence
to all processes is essential as a
fundamental requirement. It should only
be utilized after completing the Graphy
Certificate Course where the Using
Protocols are instructed.

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1. Introduction

The following manual is a comprehensive guide developed by the Graphy Technical

Support Team, aimed at practitioners, technicians, and professionals involved in the
fabrication of shape memory aligners using direct printing technology. This step-by-step
guide meticulously outlines the process, from initial software setup to the final delivery of
high-quality aligners.

Purpose of the Manual:

The purpose of this manual is to provide a detailed, structured approach to the production
of shape memory aligners using advanced direct printing techniques. By following these
instructions, users can achieve precise, customizable, and efficient fabrication of
orthodontic aligners, ensuring optimal patient care and treatment outcomes.

Overview of Contents:

The manual is divided into ten comprehensive sections, each focusing on a specific stage
of the shape memory aligner production process:

Slicing: Instructions for software installation and aligner file preparation.

Printing Aligners: Steps to initiate and confirm parameters for aligner printing.

Detaching Aligners: Safe removal procedures from the printing surface.

Centrifuging (Remove Residual Resin): Using a centrifuge to eliminate any remaining

resin.

Detaching Supports: Detailed guidance for removing printed supports with caution.

Curing (Tera Harz Cure): Post-print curing guidelines, including temperature

considerations.

Polishing: Steps for post-curing alignment surface smoothening.

Washing, Boiling & Drying: Comprehensive procedures to ensure aligner cleanliness and
integrity.

Packing & Delivery: Instructions for proper storage and packaging before delivery.

Precautions: Essential precautions to maintain aligner quality and prevent potential issues.

Scope and Benefits:

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By adhering to this manual, practitioners and technicians can ensure the precise fabrication
of shape memory aligners using direct printing technology. This comprehensive guide aims
to streamline the production process, enhance treatment efficacy, and maintain the highest
quality standards in orthodontic care.

This introduction provides an overview of the manual's purpose, contents, and the benefits
it offers to those involved in the fabrication of shape memory aligners through direct printing.

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2. Safety of Shape Memory Aligner

Shape Memory Aligners, like any medical device, prioritize safety and efficacy. These
aligners undergo rigorous testing and certifications to ensure they meet stringent safety
standards before being used in clinical settings. Here are some aspects that contribute to
the safety of Shape Memory Aligners:

FDA Approval: Graphy's Shape Memory Aligner being a Class II 510k cleared product by
the U.S. Food and Drug Administration (FDA) ensures it has passed various safety
assessments and tests.

Biocompatibility: These aligners are designed using materials that are biocompatible,
meaning they are well-tolerated by the human body without causing adverse reactions.

Testing Protocols: Aligners undergo multiple tests, including in-vitro cytotoxicity,

intracutaneous reactivity, oral mucosal irritation, skin sensitization, acute systemic toxicity,
sub-chronic toxicity, genotoxicity, and subcutaneous implantation tests to ensure they are
safe for patient use.

1. In-Vitro Cytotoxicity Test: Assesses whether a substance is toxic to cells in a cell culture
environment.
2. Intracutaneous Reactivity Test: Observes local reactions to a substance injected into the
skin.
3. Oral Mucosal Irritation Test: Evaluates irritation reactions when a substance is applied to

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the mucous membranes of the mouth.

4. Skin Sensitization Test: Tests whether a substance causes an allergic reaction on the
skin.
5. Acute Systemic Toxicity Test: Assesses the toxicity of a substance to the whole body over
a short period.
6. Sub-Chronic Toxicity Test (90days): Assesses potential toxicity over 90 days with
repeated exposure to a substance.
7. Genotoxicity-Bacterial reverse mutation (AMES) Test: Uses bacteria to assess whether a
substance causes genetic mutations.
8. Genotoxicity Chromosomal Aberration Test: Tests for abnormalities caused by a
substance on chromosomes.
9. Subcutaneous implantation Test - 13 weeks: Observes biological reactions for 13 weeks
after a substance is implanted subcutaneously in an animal.

As a result of Graphy's work environment evaluation, resin is so safe that IPA (isopropyl
alcohol) and musculoskeletal disorders were evaluated as more dangerous than resin.

Manufacturing Standards: Aligners are produced adhering to strict manufacturing standards

to maintain quality, consistency, and safety.

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3. Clinical Effectiveness & Precision

Clinical effectiveness has been proven in numerous papers.

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Shape Memory Aligner's superior precision stems from its direct printing process, distinguishing it from

traditional aligners

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4. Slicing

1. Install Uniz Slice software (Uniz Dental)

- Download Link for Uniz Dental :

https://www.uniz.com/eu_en/support/support_installing_uniz_dental/

2. Begin by clicking on the UNIZ Dental SW icon located on your desktop after installing
‘Uniz Dental’.

3. Click on the "Open" icon to import the aligner shell files (in STL format)

4. If there is an exclamation mark, please go to Repair function.

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5. Repair – Repair Model

6. After executing Repair Model, you can see that the An Exclamation mark has been
disappeared.

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7. Please use the mouse to position and organize the aligners.

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8. On the right side of the interface, locate and click on the "Profile" section. From the
options provided, please select ‘Graphy TC-85DAC 0.05_default’ or ‘Graphy TC-85DAC
0.1_default’.

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9. To save the file for printing, click the 'Slice' button. After slicing is complete, click on the
'Save' button. Save the file as '*.zslr' format with the desired name on USB driver. Sending
the sliced file to the printer by using USB driver or LAN.

* If you intend to save the project file, kindly save it in the ‘zprj’ format.

* We are assessing the calibration status and parameter configuration by using the below
cube specimens prior to the fabrication of actual aligners.

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For the printed cubes, an isopropyl alcohol (IPA) washing procedure is essential, using an
ultrasonic cleaner to ensure precision in measurement. Following below 0.5 ~ 1 minute IPA
cleaning duration and subsequent 20-minutes at Lv2 curing period with nitrogen, it is
important to verify the dimensional accuracy of the cubes.

* For access to the STL files to the cubes, kindly contact Graphy.

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5. Printing aligners

1. Insert the USB driver containing the saved sliced file into the USB port on the left side of
the NBEE Printer.

2 On the printer's display, click on the second icon located on the left side. Then click on the
designated area marked in red.

3. To begin the printing process, click the “Play button” After that you can see check lists
: “Making sure the build plate is empty and the resin tank is stirred”

4. To begin the printing process, click the ‘Confirm’ button.

* For TC-85DAC resin, preheating at room temperature is not required.

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6. Detaching aligners from the build plate

1. After the printing process is done, please remove the build plate from the printer.

2. Once you have the plate in hand, gently detach the direct aligners from the plate using a
spatula.

3. Take your time during this step to avoid applying excessive force, as it could potentially
damage the aligners.

4. The sharper the spatula, the more smoothly the aligner can be detached.

5. After taking out the printed aligners, use a paper towel to thoroughly wipe the build plate.
Then, fastened the build plate onto the printer and close the lid.

* Please exercise caution when using the sharp spatula, as it can harm your hands.

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7. Centrifuging (Remove Residual Resin)

1. Remove any remaining resin from the printouts using a Tera Harz Spinner
(Centrifuge).

2. Please use the centrifuge provided by Graphy to eliminate any residual resin.

3. To clean the aligners, avoid using alcohol or IPA, as this can cause opacity and alter
their physical properties.

4. Open the lid of the Tera Harz Spinner and place the aligners inside.

5. When placing the aligner in the basket, ensure that the inside of the aligner is facing
the wall of the basket.

6. Close the lid securely.

7. Connect the Tera Harz Spinner to power, adjust the dial to 6 minutes, and it will start
automatically, accompanied by a beep sound after a brief period .

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When the aligner direction is against inner When the aligner direction is facing inner
wall. wall.

8. When using more than two aligners in a rotational configuration, it is advisable to arrange
them in a diametrically opposed manner. At the high RPM, the equilibrium of a centrifuge
may be unstable unless equivalent masses are situated in opposite positions within the
rotor.

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balanced unbalanced

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8. Detaching Supports

1. Ensure that the gloves you use are clean and free of any residual resin while removing
the supports.

** Wearing gloves with residual resin when removing supports could transfer excess resin
into the aligners, potentially impacting their fit and transparency.

2. Once the centrifuging process is complete, proceed to detach the supports.

3. The supports can be easily removed by hand but ensure gentle handling to prevent any
damage to the aligners or attachments.

4. Please exercise caution and refrain from inserting your fingers into the aligners when
removing supports.
There is a high risk that any remains or particles inadvertently introduced into the aligners
may lead to
an improper fit.

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For aligners with attachments:

1. Pay special attention to the attachments.

2. Thoroughly check for any residual resin that might be trapped inside.

3. If any resin is found within the attachments, carefully wipe them using a cotton swab
or high-quality small paintbrush. It is essential to ensure that the attachments are
completely free from any residual resin.

** If the bristles of the brush fall out, they can stick to the aligner and increase working time,
so we recommend using a high-quality small paint brush that does not shed bristles.

5. When using a brush to clean the aligner, hold onto the occlusal surface and trim line.
Avoid touching the labial and lingual surfaces with gloves, as it may lead to cloudiness of
the aligners.

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9. Curing (Tera Harz Cure 2)

* While curing, it's crucial to maintain the compressor pressure at or above 7 bar.

1. Place the aligners on the reflector plate with the incisal/ occlusal edge facing upwards.

2. Carefully position the aligners to prevent any distortion to their shape.

3. The aligners should be evenly spaced and not stuck together.

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* If the curing process is performed while the aligners are interconnected, separating them
after post-curing could prove challenging, potentially leaving the aligners unusable.

4. Once the aligners are correctly positioned, place them onto the reflective plate within the
curing chamber.

5. Ensure a proper alignment between the plate's perforations and the chamber's
protrusions to facilitate smooth rotation of the plate during the curing process.

6. Press the Nitrogen injection button(N2) displayed on the screen and initiate level 2 curing
for 20 minutes.

Min(0~60), Sec(0~55), Level(1~5)

7. Before the actual curing begins, the machine will require approximately 3 minutes to fill
the chamber with nitrogen.

8. Keep in mind that the exact curing time might vary based on the shape and thickness of
the aligners.

9. Immediately after the curing process is complete. The internal temperature of the curing
machine tends to be higher than optimal levels.

To maintain the quality and effectiveness of our products, we kindly advise that you take the
following steps:

Cooling:

Upon completion of the curing process, please ensure to open the curing machine door for
approximately 20 to 30 minutes. This will allow the internal temperature to gradually
decrease to an optimal level (below 23 °C). Proper ventilation and cooling during this phase
are crucial to ensuring the desired material characteristics and LED performance.

Temperature Impact on LED Output:

It's important to note that temperature directly impacts both the material properties and the

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output of LED lights. In general, a cooler environment leads to higher light output from
LEDs. Conversely, higher temperatures tend to reduce light output, which can subsequently
affect the overall curing process and the final quality of our products.

10. In some instances, if an aligner is not cured well, it may exhibit a yellowish color, which
can impact both its appearance and functionality.

11. We strongly advise against using the aligners if they display yellowish color due to
insufficient curing like right a sample.

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12. Keep the Tera Harz Cure plate clean at all times.
To facilitate effective cleaning, we recommend performing the following steps :

Regular Cleaning:

To ensure the cleanliness and safety of the Tera Harz Cure Plate, it is essential to perform
routine maintenance. Ideally, clean the plate after daily use by using Isopropyl Alcohol (IPA)
and a paper towel thoroughly. This practice will effectively remove any contaminants and
maintain the plate's pristine condition.

However, if daily cleaning proves challenging due to time constraints, then clean the Tera
Harz Cure plate at least once a week. This routine maintenance will prevent the buildup of
residue and contaminants that could affect the quality of the aligner.

X O

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10. Polishing

1. Once the aligner has undergone the curing process, ensure it cools down sufficiently
before proceeding with the polishing.

2. For the polishing procedure, use a soft denture pad. Gently polish the areas where the
support marks are present.

3. The objective is to achieve a smooth and polished surface without compromising the
integrity of the aligner.

4. Once the polishing is completed, it is recommended to wash the aligner with water.

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Before Polishing After Polishing

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11. Washing, Boiling & Drying

1. The first washing is placing the aligners in a hot water bath (80 ˚C ~ 85 ˚C) for 2 minutes
with ultrasonic cleaning.
* The primary objective of ultrasonication is to thoroughly clean and eliminate any residual
dust particles that might remain on the surface even after the polishing stage.

2. After the first wash, rinse the aligners with distilled water or clean water.

3. The second wash is rinsing the aligners in boiling water (100 ˚C) for 1 minute.

* The Primary objective of the boiling process step serves a dual purpose: Quality
Assurance and Sterilization.
Through the boiling process, we ensure the aligners are free from any potential
contaminants, thereby maintaining the highest level of hygiene. Additionally, this process
aids in determining the polymerization status of the aligners.
Should an aligner exhibit haziness after the boiling process, it's indicative that the
polymerization is not at 100%.
This situation is likely a result of not adhering to the post-curing workflow.

4. After the boiling process, rinse the aligners with distilled water or clean water and dry
them.

Drying
Aligners should be dried before storing or packaging because the prolonged exposure to
moisture can compromise the structural integrity of the aligner and may lead to the growth
of bacteria or fungi, affecting the hygiene of the aligners and potentially causing damage.
Additionally, wet conditions can affect the physical properties of the aligners, such as
flexibility and fit, which are crucial for effective orthodontic treatment.

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Be sure to follow the instructions below.

- When putting aligners in the water or taking them out, make sure to do it all at once.

- During the boiling procedure, submerge the aligners inside in boiling water precisely for 1
minute.

- Ensure that there is enough water in the ultrasonic cleaning and boiling to fully submerge
the aligners.

- Do not use the same water for more than 3 times in the ultrasonic cleaning and boiling
process.

- After boiling, you can check whether the aligner has cured well or not by checking its
transparency.

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Please refer to the image: the top part is uncured, and the bottom part is fully cured.

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12. Packing & Delivery

After completing the drying process, it is crucial to store the Direct Aligner in its designated
packaging container. The packaging container should be designed to shield the aligner from
UV light exposure, which could potentially affect its integrity. UV light can have adverse
effects on the aligner material, so it's essential to prevent any exposure.

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13. Precautions

1. After 3D printing, aligners must be started to cure immediately (within at least 1 hour).

2. To maintain the integrity of the aligner, avoid excessive bending or twisting of the printed
material. Overly bending or twisting the aligner can compromise its shape memory and
overall effectiveness.

3. First time before wearing the aligners, it's best to immerse them in hot water at over 80
˚C for around 5-10 seconds once for each step in the process

* This is because the molecular structure of the aligner is stabilized to enhance durability, and sometimes
sensitive patients report that the aligner emits an odor.

4. Patients should brush their aligners at least once a day and boil them for 1 minute to
effectively disinfect and maintain their cleanliness.

5. Depending on the region, tap water may be used during the ultrasonic cleaning and
boiling process, but as most water contains minerals or calcium, it is recommended to use
distilled water or de-mineralized water.

6. The certain situations, may arise where the aligners might get contaminated or change
color.

Tera Harz Care offers two primary functionalities that are sure to
make your aligner journey even more convenient:

Effective Cleaning: Tera Harz Care employs advanced ultrasonic

technology to provide a thorough and efficient cleaning process. It
can effectively remove contaminants and stains that may have
accumulated on your aligners throughout the day, ensuring they
remain fresh and hygienic. Any dental appliance that is not cleaned
properly can become a breeding ground for plaque posing a serious

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risk to those wearing it, as well as looking cloudy and dull.

Enhanced Fit: In addition to its cleaning capabilities, the Tera Harz Care can gently warm
your aligners, making them softer and more pliable. This feature helps to achieve a better fit
for your aligners, enhancing their comfort and overall effectiveness.

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14. Clinical Issues with Graphy Shape Memory Aligner

1. Uncured Monomer can be caused by

- Insufficient chemical background knowledge and a lack of understanding of the material.

- Failure to adhere to IFU of FDA 510K and CE approved methods.

- Mainly attributed to the non-cooperation of dental technicians and printing technicians.

- A strong inclination to adhere to the existing vacuum heat fusion method.

Clinics that successfully addressed the issue with Graphy technical support did not
report a recurrence of the problem.

2. Hygiene-Related Stomatitis

- Hygiene-related stomatitis occurs with a

very consistent pattern.

- The incubation period is about 3 to 7 days,

and it mainly occurs in female patients and
is accompanied by neck pain.

- By explaining the possibility of this

phenomenon to the patient in advance, it is
possible to obtain the patient's cooperation regarding hygiene management.

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- Characterized by swelling that is much lower than tissue swelling caused by uncured
monomers.

- Cleaning the aligner through tooth brushing and sterilizing in boiling water can prevent
this phenomenon.

3. Physical Stimulation

- It is difficult to 3D scan gums, which are soft tissues, compared to teeth, which are hard
tissues.

- If an error occurs in setting the boundary angle near the gingiva, the device will stimulate
the inside of the oral cavity.

- Patients should be able to easily adapt to the treatment by starting with scallop margins
and then progressing to extended scallop margins and straight margins.

- Stomatitis caused by physical irritation is similar to buying new shoes.

- If discomfort occurs with the new aligner, it can be easily resolved by taking a break from
using it for a while and then wearing it again after the problem has been resolved.

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