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Found 3 results
510(k) Data Aggregation
K Number
K980864Device Name
POWER COINS GLOW IN THE DARK LIGATURES
Manufacturer
ORTHO KINETICS CORP.
Date Cleared
1998-04-20
(46 days)
Product Code
ECI
Regulation Number
872.5410Why did this record match?
Product Code :
ECI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.
Device Description
Not Found
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K Number
K980053Device Name
GLENROE CHAIN
Manufacturer
GLENROE TECHNOLOGIES
Date Cleared
1998-02-24
(49 days)
Product Code
ECI
Regulation Number
872.5410Why did this record match?
Product Code :
ECI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use to connect brackets and help to close gaps between teeth. They are normally used for a period of 4 to 6 weeks, then replaced with new chain.
Device Description
Glenroe Glow-In-Dark Elastomeric Ligature Chain
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K Number
K973495Device Name
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
Manufacturer
GLENROE
Date Cleared
1997-12-01
(76 days)
Product Code
ECI
Regulation Number
872.5410Why did this record match?
Product Code :
ECI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Glenroe glow in dark elastomeric ties are used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 4 to 6 weeks when they are replaced with new ties.
Device Description
Not Found
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