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510(k) Data Aggregation
K Number
K230225Device Name
DynaFlex Clear Brackets & Buttons
Manufacturer
Dyna Flex
Date Cleared
2023-06-05
(129 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Dyna Flex
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.
Device Description
DynaFlex ® Clear Brackets & Buttons is a series of clear, lightweight, ceramic brackets, and buttons. DynaFlex ® Clear Brackets & Buttons are used in the alignment of teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
DynaFlex ® Clear Brackets & Buttons are designed to move teeth to improve their alignment. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic brackets are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Bonding supplies are used to bond the bracket on to a tooth. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
DynaFlex ® Clear Brackets & Buttons may be adjusted by the dentist. The appliance is provided as a non-sterile device and is single use. DynaFlex® Clear Bracket & Buttons is for prescription only.
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K Number
K121396Device Name
DYNAFLEX
Manufacturer
DYNA FLEX
Date Cleared
2012-08-14
(97 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
DYNA FLEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state. DynaFlex EZ-Align® is for prescription only.
Device Description
DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state.
The device will be custom made for each patient and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.
Aligners are fabricated from .030 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aliener. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.
Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.
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