Search Results

The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

The Concinnity Aligners™ is a custom clear aligner system. They are a series of doctor (orthodontist or dentist) prescribed clear plastic removable aligners that are used as alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment. The Concinnity Aligners™ comes in two forms: a polyurethane-based material used to treat malocclusion in heavy bruxers, and a second form made from cycloaliphatic co-polyester polyurethane used in for all other patients. The polyurethane material is identical to the predicate device's material, and the cvcloaliphatic co-polyester and polyurethane materials are used in the reference device. The manufacturing of Concinnity™ Aligners begins with the clinician prescribing aligners to treat a patient's malocclusion. The decision to use clear aligner-based treatment is made by the clinician. In addition to the prescription the clinician also provides Drake Precision Dental Laboratory (DPDL) with a model of the patient's dentition. The clinician can generate a digital file by scanning the patient's mouth directly using Intraoral scanner (IOS) software, such as 3Shape Trios or iTero software. A mold of the patient's dentition is obtained using traditional impression material or by converting the mold to a stone model. Impressions are taken by the dental clinician and submitted to Drake Labs along with the physician's prescription. All incoming impressions are logged and tracked under the DPDL QMS system. If DPDL receives a digital file it is tracked through its QMS system without any modifications. If DPDL receives a stone model from the information is entered and tracked as per QMS. The stone model is scanned using a digital scanner and converted into a digital file. Upon receipt of traditional impression molds, they are converted to stone models which can be scanned and digitized. The digital files are sent to a third party design firm which develops the treatment plan. The third-party design firm utilizes the digital files and the prescription from the clinician to create a customized treatment plan that is reviewed and approved by the clinician. The customized plan generates a series of *.stl CAD files for building models that allow fabrication of aligners that gently move the teeth in small increments. The third party uses the 3Shape Clear Aligner Studio (K180941) to develop the treatment plan. The treatment plan is sent to the prescribing clinician for approval before it is sent back to DPDL. Once DPDL receives these *.stl CAD files of the treatment plan the CAD unit in DPDL receives the documents, updates the QMS documentation and manufacturing begins. The DPDL manufacturing unit generates sequential 3D printed models replicating the clinician approved treatment plan. The sequential models are 3D printed and are used to generate clear thermoplastic aligners. The aligners are cut to fit dentition, the cleaned and polished to remove rough edges. The sequential aligners are the packaged and labeled. Quality assurance ensures that the correct aligners are being shipped to the prescribing physician. The final product is released and shipped to the prescribing clinician who is responsible for ensuring the patient's safe use of the device. The Concinnity™ Aligners are manufactured using thermoplastic polymers used by the predicate and reference devices. Manufacturing, processing, labeling, and shipping of the aligners are performed under strict quality control procedures that ensures Concinnity Aligners™ is manufactured under the QMS. Drake Labs sends the aligners to the doctor who delivers them to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments.