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510(k) Data Aggregation
K Number
K220726Device Name
K Clear
Manufacturer
Date Cleared
2022-03-16
(2 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
K Line Europe GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
Device Description
The K Line K Clear aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a softwaregenerated sequence of intermediate states. K Clear sequentially reposition teeth by way of continuous gentle force.
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