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The intended use of composite brackets and buttons is to be bonded to the teeth to provide orthodontic movement of natural teeth. The main indication for use of orthodontic brackets and buttons is a malocclusion, such as misaligned teeth, overcrowding, spacing issues, and bite irregularities.

Composite orthodontic brackets and buttons present a clear and aesthetically pleasing choice for orthodontic patients undergoing orthodontic treatment. The Composite Bracket and Button is engineered to offer simple and aesthetic devices that address both minor and complex misalignments in patients. Composite orthodontic brackets and buttons are classified as Class II medical devices. In accordance with ISO 10993-1:2018, based on the nature of body contact, orthodontic brackets and buttons are categorized as having mucosal contact, as they are affixed to the teeth and maintain prolonged contact with the oral mucosa. Furthermore, the contact duration is categorized as "permanent exposure" (=more than thirty days), as brackets and buttons are expected to remain in place for extended periods during orthodontic treatment. Utilized by orthodontic professionals, these brackets and buttons serve as integral components - together with adhesives, wires, bands, elastics and other attachments in the alignment and correction of dental malocclusions and misalignments. The duration of the treatment depends on the degree of misalignment and is between 6 months and a maximum of 2,5 years. Brackets and buttons are strategically placed and affixed to the surface of the teeth using dental adhesive. This bonding process ensures that the brackets and buttons remain securely attached to the teeth throughout the orthodontic treatment. Then Orthodontic arch wires are pushed into the slot of the bracket. The slot acts as an aid to hold and guide the orthodontic wires that - in conjunction with bands and other orthodontic accessories - exert gentle forces to the teeth, gradually moving them into their desired position. These direct and indirect orthodontic bonding techniques with orthodontic adhesives is thoroughly documented in orthodontic literature. These additional products required for orthodontic treatment are chosen by the orthodontist as required and are hence not part of this 510(k) application. The removal of the brackets/buttons follow standard procedures that do not require additional training. Composite Orthodontic Products are only to be used by Orthodontists/Dentists. As educated specialists they know exactly how to use brackets and buttons. They have received training in order to analyse and decide with which other products they are best compatible (wires, adhesives, elastics and instruments). This 510(k) application is only for composite orthodontic brackets and buttons.

The Braces on Demand Bracket is intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.

The proposed device is a 3D-printed bracket system that directly bonds to either primary teeth, permanent teeth, or mixed dentition to provide for orthodontic treatment for patients with malocclusions. Each bracket is 3D printed using a photopolymer denture resin. The Braces on Demand Bracket System has an integral hook design, which allows for attachment of accessories such as elastics or springs to assist the clinician in producing the desired tooth movement. The hook position on the Braces on Demand brackets can be on the mesial occlusal tiewing or the distal occlusal tiewing, similar to traditional orthodontic brackets. The application and removal of the Braces on Demand brackets are similar to other orthodontic brackets in that it requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding. The bonding surface of the bracket is a mechanical dovetail undercut design, allowing the bracket to mechanically retain the adhesive and bond to the facial surface of the tooth.

Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct malocclusions in orthodontic patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time.

The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patient's orthodontist. Commercially available brackets are used as part of the system.

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.

The ORTHODONTIC PLASTIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC PLASTIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred positions can be used with bracket caps. The ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES consist of plastic orthodontic brackets, bracket caps, and buttons. The bracket caps are designed as an accessory of the orthodontic brackets for holding the archwire in the bracket's slot. Bracket caps are placed on the labial/buccal side of the brackets. The plastic buttons are designed to move teeth to improve their alignment. The plastic buttons are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. The button design includes a round slot for attaching wires or other appliances.

The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.

The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments. The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping. The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.

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.

eXceed Computerized Precision Bracket Placement Solution is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. eXceed Computerized Precision Bracket Placement Solution is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time.

The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patients Orthodontist. Commercially available brackets are used as part of the system. Using the images provided by the Dental Professional, the software creates a 3D model and identifies the ideal placement of the brackets. The file is sent to the Dental Professional for review and approval. The Dental Professional may adjust the final position of the bracket if desired. A 3D model is printed, and the brackets are placed on the model in the prescribed location, approved by the Orthodontist. An indirect bonding tray is fabricated with the brackets in place. The tray and brackets are sent to the Dental professional. The Dental Professional places the indirect tray using their chosen commercially available bracket adhesive.

The Composite Brackets are intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.

Composite brackets provide a clear, aesthetic option for patients undergoing orthodontic treatment. The Composite Bracket system is designed to provide simple, aesthetic bonded brackets to correct minor to complicated mal-alignments in patients with permanent dentition (second molars) or mixed dentition using current orthodontic diagnosing techniques with orthodontic arch wires. The system consists of a series of clear, plastic brackets that conform to each tooth and its anatomy and adheres with a bracket base bearing a mechanical retention surface. They are provided with or without a metal archwire slot. Additional accessories to the brackets, depending on the dental professionals' technique, mav include small hooks for the use of elastics and auxiliary arch wire tubes. Each bracket applies incremental, progressive force to reposition teeth to achieve ideal alignment, as prescribed by the treating dental practitioner. The composite brackets are bonded to the patient's teeth by traditional orthodontic direct and indirect bonding techniques using Orthodontic adhesives.

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.

Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient. The Insignia Orthodontic System is compatible with the iTero scanner.

The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive. Insignia with iTero consists of the following components and accessories: 1) Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) Either commercially-available or patient-specific shaped traditional archwires. The device does not include the adhesive that affixes the brackets to the teeth.