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510(k) Data Aggregation
K Number
K082838Device Name
ORLUS MINI SCREW
Manufacturer
ORTHOLUTION CO., LTD.
Date Cleared
2008-11-25
(60 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ORTHOLUTION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORLUS Mini Screw is intended for use as temporary anchor for orthodontic treatment.
Device Description
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.4~1.8mm in diameter and ranges from 5~13mm in total length. It is made of Titanium 6Al-4V alloy. There is a hole in the screw head with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
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K Number
K052968Device Name
MODIFICATION TO: ORLUS MINI SCREW
Manufacturer
ORTHOLUTION CO., LTD.
Date Cleared
2006-09-08
(322 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ORTHOLUTION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORLUS Mini Screw is intended for use as a temporary anchor for orthodontic treatment.
Device Description
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.4 - 1.8 mm in diameter and range from 5-13 mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
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K Number
K050568Device Name
ORLUS MINI SCREW
Manufacturer
ORTHOLUTION CO., LTD.
Date Cleared
2005-06-01
(89 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ORTHOLUTION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
Device Description
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.6 and 1.8 mm in diameter and range from 5-14mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
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