Consent & History

How Does the SmileDirectClub Aligner Treatment Work?

SmileDirectClub's aligner treatment is a series of clear, BPA-free plastic aligners that apply subtle pressure to gradually shift your teeth. The aligners are made to be worn in a specific sequence prescribed by your treating dentist. Each new aligner will gradually shift teeth. During treatment, an optional teeth whitening system may be used. You should be aware of the benefits and risks related to using aligners. Please be advised that you and your dentist may not be able to achieve all aspects of your chief complaint. This is due to factors beyond anyone’s control, including the guidelines and parameters that must be followed with remote aligner treatment. If, with your chief complaint in mind, your treating dentist determines you are a candidate for treatment using the SmileDirectClub aligners - and you follow your treating dentist’s instructions - you will receive the best possible outcome available using the SmileDirectClub aligner treatment. Feel free to contact the SmileDirectClub patient care team to discuss any concerns you may have or to get in touch with your treating dentist.

Your treating dentist has asked us to let you know the following:

Aligner Benefits

• DISCREET – The aligners are made of clear, BPA-free plastic. The trays are thin, lightweight and nearly invisible when worn - many people won't even know you're wearing them.

• HYGIENE – Because the aligners can be removed, you can eat, brush and floss normally, and the process of using aligners may improve your oral hygiene habits.

Aligner Contraindications

This product is not to be used by patients with the following conditions: Patients with mixed dentition, patients with permanent dental implants, patients with active periodontal disease, patients who are allergic to plastics, patients who have craniomandibular dysfunction (CMD), patients who have temporomandibular joint dysfunction (TMJ), and patients who have temporomandibular disorder (TMD).

Aligner Warnings & Precautions

• 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.

• ALLERGIC REACTION – In rare instances, some people may be allergic to the plastic aligner material or any other item material included. If this happens to you, discontinue use and consult a healthcare professional immediately.

• 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.

• CAVITIES, GUM OR PERIODONTAL DISEASE – Cavities, tooth decay, periodontal disease, gingival recession, inflammation of the gums or permanent markings (e.g. decalcification) may occur or accelerate during use of aligners. These reactions are likely not attributed to the aligners and can 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 routinely see a dentist for preventive check-ups. 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 persist unchecked, they may become more prevalent and lead 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.

• SHORTENING OF THE ROOTS/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 regular dentist during orthodontic treatment, your aligner treatment may need to be discontinued or tooth loss may occur. If a primary (or "baby") tooth is present, any orthodontic movement would accelerate the resorption process, leading to its loss.

• NERVE DAMAGE IN TEETH – An injured tooth can die over a period of time with or without aligner treatment and it may not be obvious that a tooth was previously injured. Nerve damage to an injured tooth may flare up from movement during aligner treatment and may require root canal treatment. While this seldomly occurs during aligner treatment, if and when it does it is most frequently related to a previous accident or injury. It is not possible to predict which patients may experience nerve damage during aligner treatment, but patients who have experienced tooth injury in the past or have restorative work on a tooth are at higher risk. If your regular dentist detects nerve damage prior to or during your aligner treatment, your aligner treatment may need to be discontinued or tooth loss can occur.

• TEMPOROMANDIBULAR JOINT DYSFUNCTION (TMJ) – Problems may occur in the jaw joints during aligner treatment, 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. In the event that you experience any of these symptoms, please see your regular dentist.

• IMPACTED AND SUPERNUMERARY TEETH –Teeth may present impacted or trapped below the bone or gums. Some patients are born with "extra" or supplementary teeth. If you have an impacted, un–erupted or supplementary teeth, aligner treatment may interfere with the tooth movement prescribed and may cause damage to root structures of adjacent teeth.

• 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.

• PREVIOUS DENTAL TREATMENT – Aligners may not be effective on some dental restorations. Additionally, dental restorations may require replacement due to tooth movement.

• PARTIAL OR FULL DENTURES – If you decide to move forward with orthodontic aligner treatment with the presence of a partial or full denture you may need to replace the partial or full denture after you complete your orthodontic aligner treatment as it may no longer fit due to tooth movements or changes in your bite. Any necessary replacements will be at your own expense and is not part of the orthodontic aligner treatment provided by your SmileDirectClub affiliated doctor.

• ORAL PIERCINGS – Piercings should be removed during treatment. In some circumstances, failure to do so could result in fractures to the aligners or broken teeth leading to termination of aligner treatment.

• BONDED RETAINER – Bonded retainers, attachments and buttons should be removed prior to aligner treatment. Should you choose to proceed with aligner treatment, you must first have your bonded retainers, attachments or buttons digitally removed for purposes of creating your treatment plan and expect to treat the arch on which they are placed at the time of your imaging. Further, you agree that you are responsible for having such bonded retainers, attachments or buttons removed by your regular dentist before beginning aligner treatment. You are also responsible for consulting with your regular dentist regarding the potential consequences of their removal and obtaining, at your expense, all dental care required for their removal. By signing the consent below, you are thereby confirming that you are aware that aligners cannot move your teeth effectively with these devices in place and that they must be removed prior to commencing your aligner treatment with the SmileDirectClub aligners.

• OTHER RISKS – Orthodontic treatment and the movement of teeth bring inherent and potential risks and side effects. In the case of aligner treatment, 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 treatment. The procedure required to treat this, known as a frenectomy, is not a part of your prescribed aligner treatment, but is a recommended adjunctive treatment for the best outcome and long-term stability of your smile.

• SAFETY – Aligners may break, be swallowed or inhaled. You may also have an allergic reaction to the materials used in the aligners.

• GENERAL HEALTH PROBLEMS – 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.

• DURATION AND RESULT – The 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. Your particular rate of tooth movement is impossible to predict and could take longer than anticipated. 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. Please note that the related additional costs will be your responsibility.

• RETAINERS – 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 3 weeks and then nightly from then on. You can expect a retainer to last about 6 months, but this can vary greatly from patient to patient.

• BITE ADJUSTMENT – Your bite may change during treatment and may result in temporary discomfort. Your bite may require adjustment after use of the aligners.

• 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 interproximal contact

Please reference the aligner instructions for use provided with the product for further information prior to use.

Healthy Teeth & Gums

SmileDirectClub aligners are most effective if your teeth and gums are healthy. It is your responsibility to routinely see a dentist prior to starting SmileDirectClub aligners, to verify that your teeth and gums are healthy prior to using SmileDirectClub aligners. It is also your responsibility to maintain and have follow-up dental care during and after SmileDirectClub aligner treatment.

BINDING ARBITRATION & CLASS ACTION WAIVER AGREEMENT

I agree that any and all disputes, claims or controversies directly or indirectly arising out of or relating to this Agreement or any aspect of the relationship between me, on the one hand, and SmileDirectClub, Inc., SmileDirectClub, LLC, or their parents, subsidiaries, related entities, or affiliates, or affiliated dental professionals (collectively “SDC”), on the other hand, whether based in contract, tort, statute, fraud, misrepresentation or any other legal theory – including, but not limited to, claims relating to my account, SDC products and services, communications from or on behalf of SDC, and medical malpractice disputes (“Disputes”) – shall be submitted to JAMS, or its successor, for confidential, final and binding arbitration to be resolved by a single arbitrator. I further agree that the arbitration will take place on an individual basis, that class arbitrations and class actions are not permitted, and that I am agreeing to give up the ability to participate in any class action. For avoidance of doubt, I am agreeing to give up the ability to bring a lawsuit in court (except small claims discussed below); and I am giving up the ability bring or participate in a class action in any form or forum, even if my Dispute is determined not to be subject to arbitration.

I agree that I will send notice of my Dispute to the mailing address below, and that I must wait 30 days after notice is received by SDC to initiate arbitration. If I initiate arbitration, I will do so in accordance with JAMS Streamlined Rules for Arbitration (“Rules”). The JAMS arbitrator shall resolve the Dispute and is empowered with the exclusive authority to resolve any dispute relating to the interpretation, applicability or enforceability of these terms or the formation of this Agreement, including the arbitrability of any dispute and any contention that all or any part of this Agreement is unconscionable, void or voidable. Any arbitration conducted pursuant to the terms of this Agreement shall be governed by the Federal Arbitration Act (9 U.S.C.§§ 1–16). The party that prevails in the arbitration shall be entitled to recover from the other party all reasonable attorneys’ fees, costs and expenses incurred by the prevailing party in connection with the arbitration; except that this provision shall not apply if I live in California.

The arbitration will be administered by JAMS under its Rules and will comply with the JAMS Consumer Minimum Standards (which are incorporated by reference). Notwithstanding the foregoing, I understand that I may instead litigate a Dispute in small claims court if the Dispute meets the requirements to be heard in small claims court.

I UNDERSTAND THAT I AM WAIVING ANY RIGHT I MIGHT OTHERWISE HAVE TO A TRIAL BEFORE A JUDGE OR JURY. I understand that upon initiating the arbitration in accordance with JAMS rules, I must send a copy of the Demand for Arbitration via U.S. Mail to SmileDirectClub, Inc., Attn: Legal Dept., Phillips Plaza, 414 Union Str., 8th Floor, Nashville, Tennessee 37219.

I understand and agree that SDC may, from time to time, amend this Agreement at its sole discretion, to the fullest extent permitted by law, by providing notice of the amendment to the email address that SDC has for me on file. I understand that any amendments to the Agreement will become effective 30 days after notice is provided by SDC and shall not apply to any Disputes that have accrued before the date of the amendment.

The formation, existence, construction, performance, and validity of this agreement shall be governed by the laws of the State of Tennessee and the United States, without reference to choice or conflict of law principles.

Informed Consent

TELEHEALTH – I hereby consent to use SmileDirectClub’s teledentistry platform so a state-licensed dentist and I can engage in telehealth as part of my aligner treatment. I understand that "telehealth" includes the practice of health or dental care delivery, diagnosis, consultation, treatment, and transfer of medical/dental information, both orally and visually, between me and a state licensed dental professional who has engaged SmileDirectClub to provide certain non-clinical dental support organization services.

By signing this Informed Consent, I understand that I am certifying that, except as indicated on my medical/dental history, during my most recent dental exam, my dentist has cleaned my teeth and has checked for and repaired cavities, loose or defective fillings, crowns or bridges. My dentist checked my last x-rays or has otherwise verified that I have no shortened or resorbed roots or impacted teeth. My dentist has probed or measured my gum pockets and confirmed that I do not have periodontal or gum disease. My dentist performed a full oral-cancer screening and confirmed that I do not have oral cancer. I do not have pain in any of my teeth or jaws, including but not limited to craniomandibular dysfunction (CMD), temporomandibular joint dysfunction (TMJ), or temporomandibular disorder (TMD). I further confirm that none of my teeth are loose, that I do not have any “baby teeth” and that all of my permanent teeth are present. I further consent to SmileDirectClub sharing my personal and medical information with third parties, business associates, or affiliates for the purposes of aligner treatment planning and/or manufacturing purposes.

I certify that I can read and understand English. I have read this form and fully understand the benefits and risks listed in this form related to my use of SmileDirectClub aligners. I understand that SmileDirectClub contracts with professional corporations which have engaged licensed dentists and orthodontists in the state in which I reside. I hereby provide my consent for one or more of the dentists or orthodontists affiliated with that professional corporation to review my records for potential evaluation, diagnosis, and treatment. I understand that my acceptance of the treatment plan approved by my treating dentist and presented to me prior to the onset of treatment reflects the results I expect to achieve through aligner treatment. I understand that my treatment plan may have to be modified and as a result, I may have to undergo adjustments (“touch-ups”) during my aligner treatment to achieve results agreed to in my original treatment plan. I also understand that neither the dentist who prescribes my aligner treatment nor SmileDirectClub can, with certainty, predict the events that may lead to touch-ups. I further understand that my aligner treatment will only address localized bite issues and will not specifically treat Angle’s orthodontic classifications II and III of malocclusion. In order to correct Angle’s orthodontic classifications II and III of malocclusion directly, I will need to seek more comprehensive treatment via my local dental professional. I understand that the dentist who prescribes my aligners will determine the best course of treatment for me and that I may be prescribed 22-hour aligners even if I prefer Nighttime Aligners. Lastly, I understand that for aligner treatment to achieve results agreed to in my treatment plan, I must be compliant with the treating dentist’s prescribing instructions, including those that are required via touch-ups, if applicable.

Consent to Record In-Person Communications. By signing below, I consent to SmileDirectClub recording any in-person meetings or consultations with SmileDirectClub personnel by audio and/or video means for the purpose of training of SmileDirectClub employees. I hereby grant SmileDirectClub the irrevocable right and permission to use any photographs and/or video recordings of me to use and disclose information about me for the purposes of creating photographs or video clips, as well as stand-alone pictures/graphics in which I may appear and/ or be heard, for use in internal SmileDirectClub publications and for such training. I understand SmileDirectClub's use of any photographs or video recordings will be limited to internal websites and publications. SmileDirectClub agrees that any photographs or video clips will not be used on social media or any public media platforms. The purpose of these recordings are for training purposes and for internal use only.

I understand and agree that such photographs and/or video recordings of me may be placed on the internal SmileDirectClub websites. I also understand and agree that I may be identified by name and/or title in such internal printed, websites, or broadcast information that might accompany the photographs and/or video recordings of me. I waive the right to approve the final product. I agree that all such portraits, pictures, photographs, video and audio recordings, and any reproductions thereof, and all plates, negatives, recording tape and digital files are and shall remain the property of SmileDirectClub.

I hereby release, acquit and forever discharge SmileDirectClub, its current and former directors, agents, officers and employees of the above-named entity, its affiliates or assigns, from any and all claims, demands, rights, promises, damages and liabilities arising out of or in connection with the use or distribution of said photographs and/or video recordings, including but not limited to any claims for invasion of privacy, appropriation of likeness or defamation.

Authorization and Release; Name, Image and Likeness. I further authorize SmileDirectClub’s use of photographs taken of me, including certain personal health information such as my first name and likeness, for educational and/or marketing purposes, which may result in disclosure to the general public. I acknowledge this authorization is voluntary, I will receive no financial compensation, and my participation in aligner treatment does not confer upon me any right of ownership in such photographs. I hereby release SmileDirectClub from any and all liability for any copyright, trademark, or other intellectual property-related claims by me or any third party in connection with my aligner treatment. I also understand (i) my treatment is not conditioned on my authorization of SmileDirectClub’s use of my name or likeness, (ii) I have the right to access, inspect, and receive a copy of any such photograph used by SmileDirectClub, and (iii) I can refuse to provide or otherwise revoke such authorization by contacting SmileDirectClub at CustomerCare@SmileDirectClub.com. This authorization is valid in perpetuity from the date of my consent hereto, unless earlier revoked in the manner prescribed above.

Data Aggregation, Anonymization, and De-Identification. I understand that SmileDirectClub will use, reproduce, aggregate, and modify my images and/or data to (i) create aggregated data, (ii) create de-identified or anonymized data, as described in local jurisdictional privacy laws, for the purpose of supporting SmileDirectClub’s research, development, and quality improvement purposes. Further, all rights, titles, and interest in the aggregated data, and all intellectual property rights therein, belong to and are retained solely by SmileDirectClub.

In the event that the SmileDirectClub affiliated doctor who reviews my chart and other information that I submit determines that I am not an appropriate candidate for the SmileDirectClub aligner treatment, but that I am a candidate for more advanced orthodontic treatment, I hereby consent to having all of my records in SmileDirectClub's possession (including without limitation dental impressions, digital scans, photographs, and medical history documentation) sent to a licensed dentist or orthodontist for further review and treatment planning, and I agree to being contacted directly by that dental or orthodontic provider.

I hereby warrant that I am eighteen (18) years old or more and competent to contract in my own name or, if I am less than eighteen years old, that my parent or guardian has signed this form below. This release is binding on me and my heirs, assigns and personal representatives.