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The Clear Image Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series. Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.

The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea. The Acrylic Splint Herbst Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The Acrylic Splint Herbst Appliance consists of an upper and lower acrylic splint custom fabricated to the teeth. These full arch splints are connected to each other by the Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of motion while the jaws are orientated in the biting relationship dictated by the positioning of the Herbst mechanism as it connects to the respective arch splints. The functional relationship built into the appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion of the mandible in relation to the maxilla. This forward repositioning, which is temporary while the appliance is being used, increases the pharyngeal space which assists the patient with improved air exchange. The prescribing dentist determines the exact repositioning of the lower bite via a wax construction bite obtained from the patient in the clinic. The dentist is also able to fine tune the jaw positioning clinically as needed by altering the Herbst mechanism and/or adjusting the acrylic portions of the appliance.

The Clear Image™ Aligners system is intended to correct minor discrepancies in the alignment of maloccluded anterior teeth on patients with permanent dentition (second molars) by moving the teeth with a progressive series of clear thin, thermoformed plastic aligners, fabricated in stages to gradually align the teeth over a period of several months. The aligners are completely removable by the patient and may be discontinued at any time.

Specialty Appliances' Clear Image™ Aligners primarily are directed toward treating a patient's anterior teeth. Such treatment involves the relatively minor orthodonic tooth movements intended to impact a patient's appearance and self image. The aligners are fabricated in clear, thin, thermoformed plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner. Aligners are fabricated from .035 or .040 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated. Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. Specialty Appliances fabricates its aligners from the prescription of an orthodontist or dentist. The dentist selects the teeth to be repositioned and indicates the type of movements desired. The patient's plaster models are then supplied to the laboratory by the attending orthodontist. The model is prepared to allow repositioning the target teeth. Next, an aligner is formed over the master model with the slightly altered to positions. As an aligner with a positionally-biased tooth receiving compartment is seated in the mouth, the positional distance between each compartment and its corresponding living tooth causes a subtle change in the semi-elastic structure of the aligner. In order for a slightly out of register aligner compartment to engage its target tooth, the material surrounding the aligner compartment becomes elastically loaded as if the plastic structure of the aligner were a spring. The subtle pressure of the aligners stored energy acts similar to a spring does when it is loaded. It is the slow dissipation of the stored energy in the structure of the aligner that urges the root structures of the teeth to move through the supportive bone.