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510(k) Data Aggregation
K Number
K102561Device Name
ORTHODONTIC CERAMIC BRACKET
Manufacturer
Date Cleared
2011-01-25
(140 days)
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
HT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Device Description
MISO Translucent Orthodontic Bracket is comprised of single crystal(mono clear sapphire) alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. MISO Translucent Orthodontic Bracket consists of 3parts. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placenient of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.
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