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510(k) Data Aggregation
K Number
K210320Device Name
ClearCorrect System
Manufacturer
Date Cleared
2021-08-06
(183 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
ClearCorrect LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
Device Description
The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks The corrective force to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force in directions that cannot be achieved by engaging with tooth surfaces alone.
The retainers of the ClearCorrect System are clear thermoformed appliances intended to keep the teeth from relapsing after they have been treated with aligners. Retainers are an optional component of aligner therapy. Retainers are typically prescribed for use at the conclusion of aligner treatment but can be prescribed at other times should there be a need to interrupt aligner treatment.
The engager templates of the ClearCorrect System are clear thermoformed appliances used to accurately apply composite resin attachments to the teeth as needed to achieve the desired tooth movement. The use of engagers and engager templates is an optional component of aligner treatment. Cavities are formed in the film having the desired shape, orientation and tooth position of the engager attachments to be bonded to the patient's teeth. At the time of use, the clinician fills the cavities in the engager template with light-curing composite resin. The engager template is then placed onto the patient's teeth and the resin cured. Once the resin is cured, the engager template is removed and discarded.
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