Patient Information Sheet and Informed Consent
The Byte Aus Pty Ltd ("byte", "we" or "us") Aligner Program and Nighttime Aligner Program makes it easier to have a beautiful smile, without the hassle of surgery or braces. byte connects you with dentists and, if you proceed with our services, we provide a series of clear, BPA - free plastic aligners which gently apply pressure to your teeth. This process carefully guides your teeth into a more beautiful smile. Aligners are designed for each stage of the straightening process, which typically lasts between 3 to 12 months.
The dentists in the byte network are not employed by byte and provide independent dental advice and services. During treatment in addition to receiving a prescription for this aligner program by network dentist, you have access to specialist customer support team members and clinical specialists to assist you in the process.This Information Sheet provides you with information to assist you in making a decision whether or not to use byte’s Impression Kit, Aligner Program, Nighttime Aligner Program or optional whitening products. It sets out, in general terms, the expected lasting benefits, potential difficulties and risks associated with this process. You should discuss the risks and benefits in your specific case with your dentist. Please read this Information Sheet carefully and if you have questions or concerns, contact byte’s patient care team or speak with your dentist. We are here to help you meet your goals. If you wish to proceed with our services after reading this Information Sheet, you will be asked to sign the Informed Consent section. By signing it you are telling us that you:
- Understand what you have read.
- Wish to proceed with the recommended treatment program after reviewing and considering this Information Sheet.
- If you do not want to proceed with any purchase or services after reading this Information Sheet, please let us know as soon as possible. If you have already purchased an Aligner Program or a Nighttime Aligner Program you may be subject to a printing fee.
- You should print a copy of this information sheet and keep for your records.
How byte works
Our process is easy. First, we want to find out if you are a potential candidate for our treatment. To do so, we need to take a close look at your mouth. We accomplish this by getting impressions of your teeth and also reviewing your photos and answers to our clinical questions. When you are ready to purchase the impression kit and be on this journey, we send you a kit that has everything you need to get started on the impressions.
Once you send the impression kit back, along with uploading your photos and answering clinical questions, we use Smile Science and 3d Imagery to develop a plan that will show you what your teeth could look like, subject to final approval by a local dentist in your area. If you want to move forward with that process and purchase the aligners to make it happen, our specialists will communicate with you to get the ball rolling. We finalize payment based on the options you chose, get your plan approved by a local dentist along with a prescription being issued and then develop the aligner system and ship it directly to your door. It’s that easy.
Prior to commencing any teeth straightening or teeth whitening service from byte, you must confirm by signing this Informed Consent that you have seen your regular dentist for a check-up and your dentist or other dental professional has:
- Completed a professional teeth cleaning;
- Reviewed your last x-rays;
- Checked for and repaired any cavities, loose or defective fillings, crowns or bridges;
- Checked that you do not have any 'baby teeth' and that all of your permanent teeth are present;
- Verified that you do not have any shortened or resorbed roots;
- Verified you do not have periodontal or gum disease; and
- Screened for (and confirmed that you do not have) oral cancer.
As part of your request for an Impression Kit, Aligner Program, Nighttime Aligner Program or optional whitening products, to avoid delays in treatment and/or potential rejections by network dentists assigned to your treatment, it is best that the above check-up has occurred within the last 6 months.
Soreness and mobility of the teeth is normal and expected during orthodontic treatment. However, you must not commence any byte services, and must immediately cease any already commenced byte treatment, if you experience any severe pain in your teeth or jaw, or any of your teeth become loose.
If the byte dental professional assigned to oversee your treatment recommends it, you must book an appointment with your regular dentist for another dental check-up as described above within 30 days. This is very important to ensure your oral health during the byte treatment. Failing to do so may impact your treatment and the successful results therefrom. It may also void byte’s guarantee which can be found at /pages/guarantees. Please understand, the costs of all check-ups and services provided by your regular dentist or other dentists you see outside of the network dentists affiliated with byte or byte’s clinical team will be in addition to those fees paid to byte.
byte offers a clear aligner made from BPA-Free plastic. Unlike traditional braces, byte’s aligner trays are unlikely to gain attention due to their clear, thin, and light weight structure. The removable aligners allow you to eat, brush, and floss normally, and without the undesirable side effects of braces. In addition to overall better oral hygiene, the whitening system allows you to whiten the appearance of your teeth during your treatment.
byte's Aligner Program it is not intended as a replacement to regular dental examinations and dental care. It is important that you keep up your regular dental check-ups and care while you are using byte products.
Orthodontic treatment and the movement of teeth bring inherit and potential risks and side effects. In the case of aligner therapy such risks include, but are not limited to, discomfort, swelling, sensitivity, numbness, sore jaw muscles, allergic reaction to dental materials, and unforeseen conditions that may be revealed during treatment which may necessitate extension of the original procedures or the recommendation of other patient – specific procedures. Additionally, the tissue attachment between the front teeth may become inflamed which is a common result of aligner therapy. The procedure required to treat this, known as a frenectomy, is not a part of byte's Aligner Program or Nighttime Aligner Program, but may be recommended by your dentist as an adjunctive treatment.
In rare cases people may have an allergic reaction to the materials used in the impression kit. If you have concerns, please contact byte for a complete list of ingredients. As with any dental impression, damage or loss of tooth structure, crowns, bridges, implants, bonded retainers or other dental work is possible. Please do not use the Impression Kit with partials.
Do not ingest the impression kit material. If you do and experience any health problems, please seek medical attention. As with anything placed in the mouth, choking hazard is a risk, please exercise appropriate caution. byte and clear aligner therapy should not be used by people with active periodontal disease.
byte's Aligner Program is not appropriate for all patients, and comes with some risks. These include possible:
Allergic Reaction – It is possible for some patients to become allergic to the materials used to create your aligners. If you experience a reaction, please discontinue use and inform us and your primary care provider immediately.
Black Triangles – Teeth which have been overlapped for long periods of time may be missing the gum tissue and when these teeth are aligned, a “black triangle” appears below the inter-proximal contact.
Cavities, Gum, or Periodontal Disease – Cavities, tooth decay, periodontal disease, inflammation of the gums or permanent markings (e.g. decalcification) may occur or accelerate during use of aligners. These reactions are more likely to occur if you eat or drink lots of sugary foods or beverages, or do not brush and floss your teeth before inserting the aligners, or do not see a dentist for preventative check – ups at least every six months. In addition, in some circumstances discoloration or white spots may occur; small cavities may increase in size, causing sensitivity and in some cases pain or tooth breakage; gingival inflammation may increase causing soreness and or bleeding. If underlying periodontal conditions persists unchecked, they may become more prevalent leading to tooth loss. You may have to discontinue aligner treatment. All of these symptoms will require you to seek care from a dentist of your choice.
Damage to Nerves in Teeth – Tooth movement may accelerate nerve damage or nerve death resulting in a root canal, other dental treatment, or loss of the tooth. It is not possible to predict which patients may experience nerve damage, but patients who have experienced tooth injury or had restoration work on a tooth are at higher risk. If your dentist detects nerve damage prior or during your aligner treatment, treatment may need to be discontinued or eventual tooth loss could occur.
Discomfort – Your mouth is sensitive so you can expect an adjustment period and some minor discomfort from moving your teeth. You may also experience gum, cheek or lip irritation when you initially use an aligner while these tissues adjust to contact with the aligner trays. Further, your bite may change during treatment and may result in temporary discomfort. Your bite may require adjustment after use of the aligners.
General Health Issues – Overall medical conditions such as bone, blood or hormonal disorders, and many prescription and non – prescription drugs (including bisphosphonates) can affect the movement of the teeth and the outcome.
Impacted and Supernumerary Teeth
– Teeth may become impacted or trapped below the bone or gums. Sometimes some patients are born with “extra” or supernumerary teeth. If you have impacted, unerupted or supernumerary teeth, aligners may not be an ideal option. If you have impacted teeth you may go through the impression kit process to determine if byte is right for you. Oral Piercings – Piercings are contraindicated during aligner therapy and therefore should be removed during treatment. In some circumstances, failure to do so could result in fractures aligners or broken teeth leading to termination of aligner treatment.
Previous Dental Treatment – Aligners will not move implants and may not be effective on some dental restorations, such as bridges. Additionally, dental restorations, such as crowns, veneers, or bridges, may require replacement due to tooth movement.
Safety – Aligners may break, be swallowed or inhaled. You may also have an allergic reaction to the materials used in the aligners.
Shortening or Root/Resorption – The roots of some patients’ teeth become shorter (resorption) during use of aligners. It is not possible to predict which patients will experience it, but patients who have had braces in the past are at higher risk. Resorption can impact the long – term health of teeth. If resorption is detected by your dentist during orthodontic treatment, treatment may need to be discontinued or eventful tooth loss could occur. If a primary (or “baby”) tooth is present, any orthodontic movement would accelerate the resorption process leading to its loss.
Supraeruption – If a tooth is not properly covered by an aligner, it may migrate outwards (supraeruption) leading to difficulty cleaning, gum disease, tooth decay and loss of tooth.
Temporary side effects – You may experience temporary changes in your speech or salivary flow while using aligners because of the presence of the aligner tray in your mouth.
Temporomandibular Joint Dysfunction (TMJ) – Problems may occur in the jaw joints during aligner therapy causing pain, headaches or ear problems. The following factors can contribute to this outcome: past trauma or injury, arthritis, hereditary history, tooth grinding or clenching and some medical conditions.
Molars - In most cases byte does not move molars. Aligners do not cover molars all the time. In cases where byte is not moving molars it is not necessary to cover them
Wisdom Teeth - In the vast majority of cases patients can proceed with Byte aligners with presence of wisdom teeth. Patient should consult with family dentist or oral surgeon to determine need and timing of wisdom tooth removal.
Do Not Use the product if you have the following conditions:
- severe open bites, severe overjet, severe overbite, tooth malocclusion requiring surgical correction, mixed dentition (both infant and adult teeth), dental prosthetics or dental implants, active periodontal disease, active tooth decay or dental caries, permanent retainers, mental illness or PETG material allergy.
- A Warning: In rare instances, some people may be allergic to the plastic aligner material or other included materials. If you happen to be one of them, stop using immediately and contact a health care professional immediately. Orthodontic appliances can be accidentally swallowed or aspirated and may be harmful.
- byte is suitable for non-bone Malocclusion deformity correction. When in doubt, play it safe. Call your medical professional if you’re experiencing any adverse effects and get in touch anytime at email@example.com and 1800-298-363.
- If you have any medical conditions listed here or otherwise which you believe will interfere with your use of Bye products please consult with your physician before proceeding.
Nighttime Aligner Program
Each of the risks identified herein also exist with byte's Nighttime Aligner Program. Nighttime Aligners also have some additional pros and cons to consider before choosing this option. Obviously the pros of not having to wear aligners all day and removing them in front of friends and family are great. There is also the benefit of having to remove and replace aligners less frequently, as Nighttime Aligners should be placed on after dinner and removed before breakfast (instead of standard aligners that must be removed and replaced at each meal). Remember, by their very nature, Nighttime Aligners will require longer correction time.
Generally, our average Nighttime Aligner treatment is five to six months, but your correction time will vary depending on treatment planning and requirements. There is a risk that, if you chose Nighttime Aligners, you will experience more discomfort than standard treatment, as there will be additional strain on your teeth after having the aligners off each day for long periods. Hyperbyte can help to alleviate this discomfort, but remember it may be more uncomfortable. Nighttime Aligners may increase the risk of root damage described above. You may experience other issues such as daytime wiggling of teeth and slower whitening effects as well.
Once treatment is complete, Nighttime Users may also experience a higher likelihood of shifting post treatment, which means you need to remain vigilant in wearing your retainers after treatment to avoid negative dentalrealignment. Nighttime Aligners are not suitable for all candidates, and work better with Mild crowding and Spacing issues. Further, you may see better results with standard alignment treatment.
Other Risks and Warnings
byte's Aligner Program it is not intended as a replacement to regular dental examinations and dental care. Orthodontic treatment and the movement of teeth bring inherit and potential risks and side effects. In the case of aligner therapy such risks include, but are not limited to, discomfort, swelling, sensitivity, numbness, sore jaw muscles, allergic reaction to dental materials, and unforeseen conditions that may be revealed during treatment which may necessitate extension of the original procedures or the recommendation of other patient – specific procedures. Additionally, the tissue attachment between the front teeth may become inflamed which is a common result of aligner therapy. The procedure required to treat this, known as a frenectomy, is not a part of my byte treatment, but is a recommended adjunctive treatment for the best outcome and long-term stability of my smile.
Duration and ResultsThe length of time you wear the aligners and the results depend on many factors, including, but not limited to: the severity of your case, the shape of your teeth, or the amount of time you wear the aligners per day. The average person generally wears the aligners for 4 – 8 months, but your particular rate of tooth movement is impossible to predict and could take longer. If the duration is extended beyond the original estimate, additional fees may be assessed. Difficult cases may require IPR and/or extractions with traditional braces for ideal results. Do not throw away your aligners at any point until your treatment is 100% complete and you have retainers. If at any point during treatment you are asked to go back to a previous aligner, for example if you lose an aligner, we need for you to have all of your previous aligners available.
Teeth may move again after you stop wearing the aligners. Retainers will be required to keep your teeth in their new positions for a lifetime. Your retainer should be worn full – time for 2 weeks and then nightly from then on. You can expect a retainer to last no more than one year, but this can vary greatly from patient to patient. Due to wear and tear we recommend buying new retainers at least once every six months. In order to qualify for the Byte for Life Guarantee you must: 1) purchase retainers from (a) Byte or (b) another source (so long as you keep and show valid proof of purchase on annual basis after your last retainer purchase from Byte.) Proof of purchases from other sources must also be sent to Byte within 45 days of purchase at firstname.lastname@example.org and 2) confirm at least once per year that you are actively using your retainers as directed.
Whitening RisksType of Discoloration – The whitening system will not lighten all teeth or restorations in teeth. Blue, gray, multi – colored, or striped discoloration may not respond to whitening. If you have gum recession or periodontal disease, the area of the tooth near the gum line may not respond to the whitening. Similarly, fillings, cavities or other damage will not lighten. Use of cigarettes, wine, coffee, tea, and similar stain producing agents will also slow whitening process.
White/Tooth Colored Fillings – White or tooth colored fillings will not lighten or may become softer after using the whitening system. These fillings may need to be replaced after whitening to math lighter teeth or if they become soft.
Pregnancy - For women who are or may become pregnant: I agree that, although I may start or continue treatment during pregnancy, in order to do so, I will receive authorization from my treating physician prior to starting or continuing aligner treatment. While I do not have to provide this authorization to byte, by agreeing to this section, I agree that it is my obligation to communicate with my doctor prior to starting or continuing the aligner process during pregnancy.
Sensitivity and Irritation – Gum irritation may arise from excessive use of whitening system, as throat irritation if whitening agent is swallowed. Tooth sensitivity may occur during initial use. In addition, discomfort and possible permanent nerve damage can arise if whitening agent leaks into damaged or cracked teeth fillings. Reversible – Whitened teeth can darken again over time. Reduction of certain types of foods and beverages will reduce staining of teeth.
HyperByte Proper Usage
HyperByte Disclaimer – Please do not submerge your HyperByte in water or other liquids at any time. Only use UL Certified USB chargers and cables (not included), failure to use certified chargers and cables carry a risk of damage and overheating.
Do not dispose of your Hyperbyte, even at the end of treatment. HyperBytes will not be issued if a patient has to go back into refinements.
AlternativesAlternatives to byte's Aligner Program include traditional braces, surgical options, and living with your teeth as they are.
Exchanges and Returns
If you are an Australian consumer, you have statutory rights under the Australian Consumer Law which may not be affected by the content of this Information Sheet.
If you receive a product that is damaged or faulty let us know by sending an email to email@example.com and we will replace it.
For your safety, we do not accept returns. Most products ship the same day they are ordered, or in the case of custom aligners we begin production of your custom aligners as soon as you complete your aligner purchase. Once an order has been placed we cannot accept exchanges, returns or refunds.
If you have a complaint about our services or products, please get in contact with us. We are committed to attempt to resolve issues wherever that is possible.
We ship to all Australian states and territories. Cost of International shipments are the responsibility of the customer.
Disputed or Past Due AccountsDisputed or past due accounts may result in delayed or discontinued treatment and may void your byte For Life Guarantee.
This Information Sheet was last updated in September 2020.
AGREEMENT TO ARBITRATE AND CLASS ACTION WAIVER
By agreeing to the Patient Information Sheet and Informed Consent (“Patient Consent”), you agree that you are required to resolve any claim that you may have against byte, Straight Smile, or their affiliated dental professionals (collectively byte et al.), including but not limited to medical malpractice disputes and consumer actions, will be determined on an individual basis in arbitration, as set forth in this Arbitration Agreement. This will preclude you from bringing any class, collective, or representative action against byte et al., and also will preclude you from participating in or recovering relief under any current or future class, collective, consolidated, or representative action brought against byte et al. by someone else.
Agreement to Binding Arbitration Between You and byte et al.
You and byte et al. agree that any dispute, claim or controversy arising out of or relating to (a) the Patient Consent or the existence, breach, termination, enforcement, interpretation or validity thereof, or (b) your access to or use of the services and products you order and/or receive from byte et al. at any time, whether before or after the date you agreed to the Patient Consent, will be settled by binding arbitration between you and byte et al., and not in a court of law.
You acknowledge and agree that you and byte et al. are each waiving the right to a trial by jury or to participate as a plaintiff or class member in any purported class action or representative proceeding. Unless both you and byte et al. otherwise agree in writing, any arbitration will be conducted only on an individual basis and not in a class, collective, consolidated, or representative proceeding. However, you and byte et al. each retain the right to bring an individual action in small claims court and the right to seek injunctive or other equitable relief in a court of competent jurisdiction to prevent the actual or threatened infringement, misappropriation or violation of a party's copyrights, trademarks, trade secrets, patents or other intellectual property rights.
Arbitration will be pursued by the parties before the parties go to court and such arbitration will be conducted by a single arbitrator under the rules of arbitration of the Australian Disputes Centre. If the parties are not able to decide on an arbitrator, the President of the New South Wales, Queensland, and Victoria Law Societies or his or her nominee will decide the arbitrator. Notwithstanding the foregoing, either party may pursue the protection of intellectual property rights and confidential information and to stop other illegal activities through injunctive relief or other equitable relief through the courts.
Jurisdiction and Governing Law
To the maximum extent permitted by applicable law, byte makes no representation that this site’s information, the services or products offered through the site are appropriate, available or legal in any particular location. Those who choose to access the site Information, the services and products offered through the site do so on their own initiative and are responsible for compliance with local laws, if and to the extent local laws are applicable. You agree that where permissible under Australian law, this Agreement, for all purposes and without regard to the conflict of laws, shall be governed and construed in accordance with the laws of the Delaware, of the United States. Appreciating the location of byte and you, you acknowledge and agree that byte may, in partaking in such arbitration, elect to use telephonic communications to minimize the need for long distance travel. This section will survive termination of your relationship with us.
Unless you and byte et al. otherwise agree, the arbitration will be conducted in the county where you reside. If your claim does not exceed $10,000, then the arbitration will be conducted solely on the basis of documents you and byte et al. submit to the Arbitrator, unless you request a hearing or the Arbitrator determines that a hearing is necessary. If your claim exceeds $10,000, your right to a hearing will be determined by the Australian Disputes Centre Rules of Arbitration. Subject to these rules, the Arbitrator will have the discretion to direct a reasonable exchange of information by the parties, consistent with the expedited nature of the arbitration.
The Arbitrator will render an award within the time frame specified in the Rules of the Australian Disputes Centre. Judgment on the arbitration award may be entered in any court having competent jurisdiction to do so. The Arbitrator may award declaratory or injunctive relief in favor of the claimant and only to the extent necessary to provide relief warranted by the claimant's individual claim. An Arbitrator’s decision shall be final and binding on all parties. An Arbitrator’s decision and judgment thereon shall have no precedential or collateral estoppel effect.
Your responsibility to pay any arbitration filing, administrative and arbitrator fees will be solely as set forth in the Australian Disputes Centre guidelines. However, if your claim for damages does not exceed $75,000 U.S. dollars, byte et al. will pay all such fees, unless the Arbitrator finds that either the substance of your claim or the relief sought in your Demand for Arbitration was frivolous or was brought for an improper purpose.
Severability and Survival
If any portion of this Arbitration Agreement is found to be unenforceable or unlawful for any reason, (1) the unenforceable or unlawful provision shall be severed from these terms; (2) severance of the unenforceable or unlawful provision shall have no impact whatsoever on the remainder of the Arbitration Agreement or the parties’ ability to compel arbitration of any remaining claims on an individual basis pursuant to the Arbitration Agreement; and (3) to the extent that any claims must therefore proceed on a class, collective, consolidated, or representative basis, such claims must be litigated in a civil court of competent jurisdiction and not in arbitration, and the parties agree that litigation of those claims shall be stayed pending the outcome of any individual claims in arbitration.