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The HDH Treatment Planning System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

The HDH Treatment Planning system is a software system for orthodontic diagnosis and treatment simulation utilized by dental professionals. The software imports patient 3D digital scans serving as a base for diagnosing the orthodontic treatment needs, analyzing, inspecting, measuring, and simulating tooth movements, and allows the user to develop a virtual treatment plan. The output of the treatment plan may be downloaded as files in STL format, a standard stereolithographic file format, or OBJ format, a standard 3D image format, for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.

The HIT Clear Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The HIT Clear Aligner system positions teeth by way of continuous gentle force.

A dental health care professional (e.g., orthodontist or dentist), using a standard personal computer prescribes the HIT Clear Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. The modification of the primary predicate device is a software system for orthodontic diagnosis and treatment simulation, HDH Treatment Planning software, utilized by CDB to design a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The software uses 3D scanned orthodontic models of a patient's dentition as input files serving as a base for diagnosing the orthodontic treatment needs, analyzing, inspecting, measuring, and simulating tooth movements, thereby allowing to create virtual treatment plans. The output of the treatment plan may be downloaded as files in STL format, a standard stereolithographic file format, or OBJ format, a standard 3D image format, for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, CDB produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

The Clear-Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The Clear-Aligner system positions teeth by way of continuous gentle force.

A dental health care professional (e.q. orthodontist or dentist), using a standard personal computer prescribes the Clear-Aligner system based on an assessment of thee patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. Utilizing standard dental software used for tooth alignment, CDB then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, CDB produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced in Table 1.

The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid.

CDB Self Ligating Bracket 8F is bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristic of the bracket.

The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.

CDB Flip-Slide-Clip Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire ligation

The CDB Clip, commonly known as an orthodontic ligating clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot. Together they facilitate the orthodontic movement of teeth.

The CDB Clip is a passive ligation clip which functions to retain the orthodontic archwire in the slot of an orthodontic bracket. It is made of Celcon MT 24U01 Acetal (POM) with no fillers.