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510(k) Data Aggregation
K Number
K192069Device Name
Aerodentis System
Manufacturer
Date Cleared
2020-05-06
(279 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Dror Orthodesign
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aerodentis System is indicated for use in movement and alignment of teeth during orthodontic treatment of malocclusion.
Device Description
The Aerodentis System is an orthodontic system intended to adjust the patient's teeth through movement from their initial position to the desired position as a result of pulsatile mechanical force. The device is designed to achieve orthodontic tooth movement over a period of approximately 10 hours per day (typically at night). The device is suitable for patients with full complement of permanent teeth in need of upper, lower or combined jaw treatments. The system is composed of two primary components: A custom-made, latex-free, plastic dental mouthpiece is inserted and worn by the patient according to a customized treatment prescription specified by the dental practitioner. The Personal Treatment Controller (PTC), which provides compressed air to the mouthpiece via a polyurethane tube.
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