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MEM Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The MEM Clear Aligner System repositions teeth by way of continuous gentle force.

The MEM Clear Aligner System is a customized plastic orthodontic system, consisting of a series of transparent, removable aligners prescribed by a doctor to correct misaligned or crooked teeth. These customized, removable transparent plastic aligners gradually reposition teeth with continuous gentle pressure. The product is a series of transparent, removable orthodontic aligners, custom-made according to the dentist's prescription and designed using the "3Shape A/S (K171634)" software. They are manufactured using thermoforming technology. These aligners are designed to provide a comfortable teeth straightening experience and achieve optimal correction through precise design using advanced technology.

The LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force.

Dental health professionals achieve orthodontic tooth movement through prescription of aligners which apply force to the patient's teeth so that each tooth follows a prescribed, predetermined displacement. LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state. A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability. The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with twelve-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely. The LuxCreo Clear Aligner System mechanism of operation, and software usage, are identical to the predicate devices, and support a determination of substantial equality. Both the LuxCreo Clear Aligner System and the predicate devices are manufactured from a biocompatible, non-sterile polyurethane materials that supports a determination of substantial equality.

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.

The Pearl Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by continuous gentle forces.

Pearl Clear Aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to align teeth during the orthodontic treatment of malocclusions. They are made of biocompatible thermoplastic polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Pearl Digital. Based on the dental health professional's treatment plan, Pearl Digital develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are vacuum formed on the molds. The finished, customized aligners are provided to the dental health care professional who delivers the aligners to the patients in sequential stages checking for fit and function.

Fas Aligner System is intended for the orthodontic treatment of malocclusion.

Fas Aligner System consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. This removable plastic orthodontic aligners intended as an alternative to conventional wire and bracket technology. Fas Aligner System are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist). Fas Aligner System 's staff in the Prescription and Planning area create the virtual planning including the attachments, as well as the movements they consider necessary to achieve the intended tooth correction. For this process the following previously released software Nemocast (K232549). The 3D specialists use the planned data to produce the complete product design. The responsible of the Planning/Prescription department reviews the design to verify that it has been done as required and, if necessary, proposes changes. Once the design has been approved by the clinician, the next phase of printing and preparation of models is carried out. This phase takes place in the Printer Room and is carried out by 3D Printing Technicians. For the entire manufacturing process, the models are identified with the clinical case number. The thermoforming equipment is used for the manufacturing process of the aligners. The printed model is placed on the platform and the thermoforming sheet is placed, which is made with material previously released by means of the K200125 (Erkodur). Once the printed thermoforming sheet is obtained, the contour of the thermoforming sheet is cut out, eliminating the edges. The gingival margins are trimmed. The product is not sent sterile, it is cleaned to remove all residues that may have remained from the manufacturing process. The product, the splint, is placed in labeled bags. The aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

Cristaline Aligners A FLX are series of clear, lightweight, plastic appliances, indicated for treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous force.

Cristaline Aligners Z FLX are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are manufactured using a biocompatible thermoplastic sheet composed of a composite of co-polyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Cristaline. Based on the dental health professional's treatment plan, Cristaline develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are formed on the molds. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design.

GENIOVA Aligners are indicated for use in the alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

GENIOVA aligners are thermoformed plastic aligners designed to be used in sequence to facilitate the movement of teeth to the desired final position. Sequential aligners introduce incremental movements that move teeth by a gentle continuous force. Aligners should be worn 20 to 22 hours a day and should be removed for eating and cleaning. GENIOVA aligners are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist). From the scan, specialized orthodontic CAD/CAM software is used to develop the treatment plans, which consist of sequential dental models in which the teeth are gradually realigned at each step. For these 510(k) applications, the Ortho system from 3Shape A/S (K180941) will be used. (K180941) from 3Shape A/S. Ortho System is approved for use in orthodontic model management, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has 510k clearance for intended use under FDA Classification Product Code PNN, regulation 872.5470. Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The Essix thermoplastic material used for BRIUS Clear Aligners has 510(k) clearance (K062828) for use as an aligner material; the 510(k) holder (of the material) conducted the physical properties testing for the material. The aligner trays are then delivered to the patient by the prescribing dental health professional. This dental health professional then monitors the patient's treatment from the first aligner to the delivery of the final aligner and completion of treatment. The aligners are held in place by pressure and can be removed by the patient at any time.

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.

Illusion Aligners Pro are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. Illusion Aligner Flx are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

A dental health professional (e.g., an orthodontist or a dentist) prescribes the Illusion Aligners Pro and Illusion Aligner Flx are based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes either the intraoral scans or physical impressions of the patient's teeth, determines the required corrections to align the teeth, and 3Shape's Ortho System is used for treatment planning. Illusion Aligners Pro and Illusion Aligner Flx are intraoral thermoplastic appliances that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Illusion Aligners Pro and Illusion Aligner Flx are fabricated using a three- step process. The first step is to obtain the dimensions and details of the patient's dentition. This is generally done using an intraoral scan or a physical impression. This scanned data (digital CAD/CAM models or patient models) is imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Illusion Aligners Pro and Illusion Aligner Flx utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the models needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using standard thermoforming equipment and the appropriate material as specified. The trays are provided to the dental health care professional who provides them to the patient in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished, and treatment is complete