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510(k) Data Aggregation
K Number
K211537Device Name
QuickAligners
Manufacturer
Date Cleared
2021-10-26
(161 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Oral Image, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Oral Image QuickAligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. QuickAligners position teeth by way of continuous gentle force.
Device Description
The Oral Image QuickAligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a softwaregenerated sequence of intermediate states. Based on a clinician's prescribed treatment plan, each aligner in the set is used for the specified period of time to exert gentle force to achieve progressive realignment of the final correction has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patient for 22 hours per day.
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