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510(k) Data Aggregation
K Number
K152167Device Name
BIJOU Orthodontic Ceramic Bracket
Manufacturer
Date Cleared
2016-05-27
(297 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
WORLD BIO TECH CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BIJOU Orthodontic Ceramic bracket is indicated for orthodontic movement of natural teeth.
Device Description
Orthodontic Ceramic bracket, BIJOU is composed of single crystal alumina and consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.
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K Number
K120471Device Name
MACH BRACKETS BRIGHT BRACKETS
Manufacturer
Date Cleared
2012-06-04
(109 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
WORLD BIO TECH CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed affer orthodontic treatment has been completed. The devices are intended to be single used only.
Device Description
The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket. The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%). This MACH BRACKETS are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle produce desired tooth movement.
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