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The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and tooth, palate) with primary, mixed, or permanent dention during orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

The subject device, Invisalign Palatal Expander (IPE) System (hereafter referred to as the IPE System) is a modification to the legally marketed multiple predicate devices. Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secondary. The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template and the proprietary 3D Shape generation software. Invisalign Palatal Expanders are a staged series of removable orthodontic devices designed to expand the patient's skeletal and/or dental narrow maxilla (upper jaw, dental arch, teeth and palate) in small increments to an optimal position determined by the doctor. Once the desired clinical outcome of the expansion phase has been achieved, patients progress to the holding phase. The Invisalign Palatal Holder is a copy of the last stage of the expansion phase designed to hold the maxilla post active expansion, to allow the maxilla to stabilize before the patient progresses to the next phase of treatment (retention, phase 2 or other treatment). The proprietary Align internal personnel-facing 3D software enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device. Using this software, CAD designers create digital files for the incremental stages of the doctorprescribed expansion amount and the design and quantity of holders per the prescribed holding duration. Each device in the series is fabricated via additive manufacturing (3D printing). The Attachment Template (also a component of the primary predicate device, the Invisalign System) enables correct placement and bonding of attachments made of dental composite (material provided by doctor) to the tooth surface for IPE engagement and retention.

The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patientmatched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.

CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.

CompleClear Plastic Orthodontic Bracket and Wire Appliance is an orthodontic appliance consisting of a polysulfone bracket with two separate components (tooth component and wire component) and an orthodontic wire pre-attached to the wire component of the bracket. The tooth and the wire components are capable of mechanically interlocking to form a detachable and reattachable bracket assembly. The tooth component of the bracket is cemented to the tooth, like regular orthodontic brackets. The wire components are pre-attached at specific positions along the orthodontic wire. The orthodontic wire is customized for each patient by creating various bends and rotations along the wire. This configuration of the customized wire, results in a specific position and orientation of the wire components of the bracket system along the customized wire. This customized orthodontic wire along with the series of pre-attached wire components constitutes the 'aligner'. When the wire components of the 'aligner' are engaged on to the corresponding tooth component cemented on the tooth, the orthodontic wire is activated like a spring. The tooth is gently moved to its desired position due to the elastic recoil of the wire. The two component bracket assembly of the present device allows moment arms for mesiodistal rotation, labio-lingual inclination and mesio-distal angulations (tip) similar to conventional bracket-wire used in orthodontics. The treatment uses a series of aligners, each incorporating a predefined amount to tooth movement toward the final desired end goal. The amount of tooth movement incorporated, the type of tooth movement incorporated and the final desired end goal are all determined and approved by the provider.

- 1. A device to be used for the treatment of sleep bruxism and - 2. As an aid in the treatment of associated tension/migraine type headaches in adults.

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Wire Sterilization Package with Indicators is intended to be used to enclose and package American Orthodontics' line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to steam or ethylene oxide gas and distinguish between processed and unprocessed wire.

American Orthodontics' Wire Sterilization Package with indicators is manufactured from bleached surgical paper and plastic film with external chemical process indicators. This packaging is a pouch that is enclosed on all four sides and contains a single arch wire. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. Upon completion of the sterilization process, the enclosed arch wire is intended to be used immediately. This packaging is not offered as a stand-alone product, but is strictly used for the packaging of American Orthodontics' Arch Wires (Classification Code: DZC; 510(k) Exempt). The bleached surgical paper conforms to the FDA 21CFR186.1673 and can be sterilized using steam or ethylene oxide gas. The plastic film is sealed to the bleached surgical paper and conforms to 21CFR177.1630 (Polyester), 21CFR175.105 (Adhesive) and 21CFR177.1520 (Polypropylene). The process indicators meet the performance requirements of AAMI/ANSI/ISO 11140-1:2014.

Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.

Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.

The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.

ClearArch is a polymer-based orthodontic archwire for maxillary and mandibular arches. The wire material 1) is more aesthetic than conventional metal wires, 2) can take different shapes, including round, rectangular and square cross-sections, 3) can be bent like TMA and 4) delivers orthodontic forces similar to nickel titanium archwires. This archwire is intended to be used during the first two phases of orthodontic treatment. Its stiffness and strength are similar to the properties of metal orthodontic archwires in order to aid in efficient tooth movement during orthodontic treatment. Therefore, orthodontists can use an esthetic archwire in lieu of a less esthetic metal version without compromising treatment mechanics.

An orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.

The BioMers Translucent Orthodontic Wire is a translucent arch wire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases theabrasion resistance properties of the wire.

LingLock is an interlock retainer composed of polycrystalline alumina that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.

The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide) that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. LingLock is comprised of a set of ceramic attachments (male/female) bonded to the teeth across the contact points of the lower six anterior front teeth; the male component on one side and the female component on the other. When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner. The LingLock retainer has an application tool consisting of a ceramic attachment holder (polypropylene) and a guide strip (stainless steel) which ensures an exact positioning of the ceramic attachments both in relation to each other and the teeth to be retained. An orthodontic adhesive is placed on the bonding surface of the ceramic attachments and the guide strip is guided in between two neighbouring teeth. The ceramic attachment holder is brought in contact with the enamel at the lingual surface of the teeth and the orthodontic adhesive is light cured. After curing, the guide strip is removed by pulling it forward in a slight upward rotational movement. The ceramic attachment holder is then removed.