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510(k) Data Aggregation
K Number
K202685Device Name
Eon Aligner
Manufacturer
Date Cleared
2020-09-28
(13 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Eon Dental Jordan LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Eon Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Eon Aligner System positions teeth by way of continuous gentle force.
Device Description
The Eon Aligners is a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as alternative 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.
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