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510(k) Data Aggregation
K Number
K090567Device Name
ORTHODONTIC CERAMIC BRACKET
Manufacturer
STAR DENTECH KOREA., CORP
Date Cleared
2009-05-27
(85 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
STAR DENTECH KOREA., CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth
Device Description
Orthodontic Ceramic bracket, "ABSOLUTE" is made of alumina single crystal (mono clean sapphire) intended to be placed on teeth to straighten teeth. ABSOLUTE ceramic bracket consists of 3 parts. The first part is slot part is a ABOOLOTE ocramic bracket sencond part is round groove part that is to hold a wire with elastic "O" ring. And, the third part is base part is to adhere to tooth surface. Also, it has a marking on fore surface to indicate a location.
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