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The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner manufacture are supported by a proprietary software system. The clinician receives the aligners and provides them in sequential "stages" to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligners are held in place by presure and can be removed by the patient at any time. Several treatment options may be integrated into the Spark Clear Aligners, such as cutouts, hooks, and/or other attachment shapes, bite ramps, etc. to aid the aligners with teeth movement. The integrated occlusion guides on the upper and lower aligners allow the option of incrementally repositioning the mandible (lower jaw) forward to address in patients who have not reached full skeletal maturity.

Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement without etching. Ormco™ EtchFree Adhesive is a light-curing adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.

The Ormco™ Bonding System consists of a primer, a sealant, an adhesive, and bonding accessories. · Ormco™ Bonding Primer is intended to bond orthodontic appliances such as metal brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement. The primer is a clear liquid that conditions the surface of the application of a bonding sealant/enhancer. Ormco Bonding Primer is designed to be used as a system along with Ortho Solo and Ormco" Bonding Adhesive. The primer is offered in single-use vials which will be sold in kits and separately. · Ormco™ Adhesive is a light-curing composite that is intended to be used with metal and ceramic brackets for orthodontic treatment and can also be used as aligner attachment. It is a convenient off-white paste providing aesthetics when used as aligner attachments or beneath a bracket. The adhesive is designed to be used as a system along with Ormco Bonding Primer and Ortho Solo. The adhesive is offered in syringes for multi-patient use, which will be sold in kits and separately.

The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear, plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner design, and aligner manufacture are supported by a proprietary software system. The clinician receives the aligners and provides them in sequential "stages" to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The aligners are held in place by pressure and can be removed by the patient at any time. The aligners are individually identified and dispensed to patients and are to be worn in a specific prescribed sequence. Several treatment options may be integrated into the Spark Clear Aligners consisting of: • Attachments: Attachments are small protuberances of tooth-colored dental bonding material and may be prescribed by the dental clinician to act as anchor points on the teeth to focus the forces of the aligner to help with teeth movement. o Templates: Attachments are placed onto the teeth via Templates. The dental practitioner may choose a standard dental composite, to fill into the Template themselves, and adhesive to bond the attachments onto the dentition. The option for composite material to be prefilled into the Template during manufacturing is also available via Prefilled Attachment (PFA) Templates. • Hooks & Cutouts: Hooks and Cutouts may be designed into the aligner to accommodate elastics for aiding in applying additional aligner forces. Integrated Hooks are an optional alternative to the traditional Hooks. • Bite ramps: Bite ramps are step features built into the lingual surfaces of the upper and lower aligner arch that are used by the clinician to prop open the bite temporarily so that certain teeth have a clearer path for movement without interference. • Pontics: Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to fill voids of missing teeth or other gaps that the clinician may wish to retain during treatment. · Posterior Bite Turbos: Posterior Bite Turbos (PBT) are designed to prevent complete closure of jaws.

SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. SparkTM Software System: The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templatesor based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

The Ormco Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, Approver, and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners. The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of: Attachments, Hooks, Bite ramps, Pontics, Posterior Bite Turbos.

This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed.

Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alumina. This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. To aid with visual placement of the bracket to the tooth surface, the bracket has a removable, color coded, plastic axis indicator that is lifted away from the bracket following tooth placement or temporary color coded labial tie wings that are removed with a toothbrush and water. To identify tooth designation, the brackets include a temporary ink dot that is removed with a toothbrush and water after the brackets have been placed on the tooth. After the brackets are placed, an archwire is then inserted / threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Symetri Clear Debonding Instrument / Pliers. This step is also known as debonding.

Inspire ICE, a ceramic orthodontic bracket, is intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed.

Inspire ICE, is a single-use orthodontic bracket made from monocrystalline alumina. The brackets are intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. An archwire is then threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Inspire ICE Debonding Pliers. This step is also known as debonding.