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Vapor® Ceramic Brackets are intended for orthodontic movement of natural teeth.

Ceramic orthodontic brackets are small devices that are intended to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. They are indicated for orthodontic treatment in patients of all ages when prescribed by an orthodontist. Ceramic orthodontic brackets are primarily offered as an aesthetic alternative to metal orthodontic brackets. They are close to natural tooth coloring, and blend in well enough that they are not as visible as metal brackets. This aesthetic look is popular with many patients, and especially older patients. Ceramic orthodontic brackets have been in use throughout the orthodontic industry for approximately thirty years. Like its predicate, Vapor® ceramic brackets are manufactured from polycrystalline alumina (ceramic) material, and have bases that are designed to provide maximum adhesion to the tooth while still allowing for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth. Like its predicate, Vapor® ceramic brackets do not incorporate medicinal substances, tissues, or blood products. They do not include software or accessories, and are delivered non-sterile to the end user. Ceramic brackets are intended to be used only once by a single patient. Product labels contain appropriate "do not reuse" symbols. Orthodontic ceramic brackets are used for the duration of orthodontic treatment, which can last more than 30 months. During this time, the devices remain in direct contact with the patient's oral cavity. Because the intended purpose of the device is clearly understood by licensed orthodontists, instructions for use are not provided. With the exception of the materials from which they are constructed, the form, fit, and function of orthodontic ceramic brackets are identical to those of traditional metal orthodontic brackets. Orthodontic ceramic brackets, like metal brackets achieve their intended purpose (to move teeth into a desired position) through industry standard "prescriptions" that are pre-programmed into the design of the brackets. That is, specific torques, angulations, and distal offset dimensions are designed into each bracket, along with archwire slots that are designed to accommodate the correct size archwire (typically .018" or .022" thick). Ceramic brackets are designed with tie wing undercut spaces for orthodontic ligatures. They have a molded ceramic bracket body with rounded corners and edges, and rounded hooks on the distal-qingival tie wings to accommodate ligation during orthodontic treatment. These design characteristics allow a tensioned ligating wire to move the brackets, which are securely bonded to the teeth, along a pre-determined path until the desired tooth position is reached. Elastic ligatures may be used on the tie wings and hooks to further facilitate tooth movement, and to secure the orthodontic wire into the bracket's archwire slot.

FastBraces® Ceramic Brackets are indicated for orthodontic movement of natural teeth.

Ceramic orthodontic brackets are small devices that are intended to teeth, upon which an orthodontic wire is placed to move the teeth to desired positions. They are indicated for orthodontic treatment in patients of all ages when prescribed by an orthodontist. Ceramic orthodontic brackets are primarily offered as an aesthetic alternative to metal orthodontic brackets. They are close to natural tooth coloring, and blend in well enough that they are not as visible as metal brackets. This aesthetic look is popular with many patients, and especially older patients. Ceramic orthodontic brackets have been in use throughout the orthodontic industry for approximately thirty years. Like its predicate, FastBraces® ceramic brackets are manufactured from polycrystalline alumina (ceramic) material, and have bases that are designed to provide maximum adhesion to the tooth while still allowing for easy and complete removal when necessary. The brackets incorporate a water soluble color placement dot as an indicator for correct selection of brackets for each tooth. Like its predicate. FastBraces® ceramic brackets do not incorporate medicinal substances, tissues, or blood products. They do not include software or accessories, and are delivered non-sterile to the end user. Ceramic brackets are intended to be used only once by a single patient. Product labels contain appropriate "do not reuse" symbols. Orthodontic ceramic brackets are used for the duration of orthodontic treatment, which can last more than 30 months. During this time, the devices remain in direct contact with the patient's oral cavity. Because the intended purpose of the device is clearly understood by licensed orthodontists, instructions for use are not provided. With the exception of the materials from which they are constructed, the form, fit, and function of orthodontic ceramic brackets are identical to those of traditional metal orthodontic brackets. Orthodontic ceramic brackets, like metal brackets achieve their intended purpose (to move teeth into a desired position) through industry standard "prescriptions" that are programmed into the design of the brackets. Specific torques, angulations, and distal offset dimensions are designed into each bracket, along with archwire slots that are designed to accommodate the correct size archwire (typically .018" or .022" thick). Ceramic brackets are designed with tie wing undercut spaces for orthodontic ligatures. They have a molded ceramic bracket body with rounded corners and edges, and rounded hooks on the distal-gingival tie wings to accommodate ligation during orthodontic treatment. These design characteristics allow a tensioned ligating wire to move the brackets, which are securely bonded to the teeth, along a pre-determined path until the desired tooth position is reached. Elastic ligatures may be used on the tie wings and hooks to further facilitate tooth movement, and to secure the orthodontic wire into the bracket's archwire slot.