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BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel. BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

American Orthodontics' BracePaste Fluoride Sealant is a light-curing primer that is intended for use in orthodontic treatment as diagnosed by a trained dental professional or orthodontist. The primer prepares the enamel during orthodontic treatment to increase adhesion to the bonding surface by wetting the bonding surface of the object to be bonded.

The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth. The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

The Cleo bracket line of products are single-use ceramic orthodontic brackets intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. The Cleo bracket line of products are made of 99.9% alumina through the process of ceramic injection molding. Visual placement aids (VPAs) are placed in the Cleo bracket line to help provide visual contrast at the arch wire slot and intertwin areas of the bracket. The VPA is removed from the bracket before orthodontic treatment begins; VPAs do not serve a function during the orthodontic treatment. The presence of the VPA within the bracket prior to treatment will not impact the safety and performance of the bracket during the device's intended use. The VPAs are made of polyurethane raw material through the process of injection molding.

A light cure orthodontic band cement intended to bond orthodontic bands to teeth.

American Orthodontics' BracePaste Band and Build LC is a light-cure band cement that is intended to bond orthodontic bands to teeth. When an orthodontic band is required for orthodontic treatment, band cement is applied to the inside of the orthodontic band and then the band is seated onto the tooth. Once the band is seated properly, excess adhesive is cleaned up from the proximity of the band and tooth and the adhesive is cured via curing light. The polymerization of the adhesive forms a bond between the orthodontic band and / or the tooth enamel. Upon completion of orthodontic treatment, the orthodontic band is removed and any adhesive remaining on tooth enamel is cleaned up and removed from the tooth.

Orthodontic Primers are intended to be used in the bonding procedure (direct or indirect) of brackets and tubes by preparing the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The Primer wets the bonding surface of the object to be bonded (i.e. enamel, composite materials, etc.) to promote adhesion.

American Orthodontics' BracePaste MTP Light Cure Primer is a light-curing primer that is intended to be used in direct or indirect bonding procedures of brackets and tubes. The primer prepares the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The primer "wets" the bonding surface of the object to be bonded [i.e. enamel, composite materials, etc.) to promote adhesion. The primer will be available in liquid form in a dropper bottle. The primer contains Bisphenol a Diglycidyl Ether Dimethacrylate and 2-Hydroxyethyl Methacrylate resin compounds. These resin compounds are mixed with ethyl alcohol and water to form an aqueous solution. This solution has the hydrophilic characteristics necessary for the primer to adhere under wet conditions. Using a curing light, the irradiation causes the methylacrylate resins to undergo polymerization. This polymerization forms a bond between the etched enamel surface and the bracket adhesive.

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative material. The Acid Etchant will be available in gel and liquid form. The gel form will be contained in syringes and the liquid form will be contained in dropper bottles. Applicator tips will be provided with the gel form. The Acid Etchant contains water, 37% phosphoric acid (CAS# 7664-38-2), silica and green dye. The silica is used as a thickener. The amount of silica will determine the flow behavior and viscosity of the Acid Etchant. The green dye is to provide contrast to the tooth's color. The combination of the flow behavior, delivery system and green dye provides and facilitates accurate and controlled application of the Acid Etchant during orthodontic treatment.

American Orthodontics' BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.

BracePaste™ Adhesive is a light-curing adhesive used as an orthodontic bonding agent for metal brackets, ceramic brackets and buccal tubes. The adhesive will be offered in syringe and carpule containers which will allow a precise volume to be dispensed during orthodontic treatment. The flow consistency (medium viscosity) of the adhesive allows for easy manipulation, yet does not allow bracket "drift" during placement. The flowable consistency also allows for precise dispensing and application of the adhesive. The adhesive contains Bis GMA and Bis EMA as resin fillers. A combination of silanized strontium aluminum boron silicate glass and silanized silica is used as fillers (Silane Treated Quartz; Silane Treated Silica). The inorganic loading is approximately 72% by weight. When exposed to light by a photoinitiator system, the methacrylate functionalities of the resin and fillers undergo a polymerization reaction which hardens or "cures" the adhesive. The adhesive in turn will create a "bond" to which the orthodontic appliance becomes attached to etched enamel surface.

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.

Empower Clear brackets are intended for orthodontic movement of teeth as diagnosed by an orthodontist. It is used temporarily and is removed upon completion of orthodontic treatment. Empower Clear brackets are intended to be single use only.

The Empower Clear line of products is single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The Ceramic Bracket combines the aesthetics of a ceramic bracket with the versatility and ease of self ligation. These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the tooth and also impart the axial control of the energy from the archwire.

Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth.

An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typically ten brackets on each of the upper and lower arches) and the wire is held in place in each bracket slot with an elastic o-ring placed under the tie wings and over the arch wire.