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Found 4 results
510(k) Data Aggregation
K Number
K112707Device Name
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
Manufacturer
ORTHO TECHNOLOGY, INC
Date Cleared
2012-01-13
(116 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
ORTHO TECHNOLOGY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teeth.
Device Description
Generation CTM Aesthetic Self-Ligating Bracket System
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K Number
K073045Device Name
SAPPHIRE CERAMIC BRACKET
Manufacturer
ORTHO TECHNOLOGY, INC
Date Cleared
2007-12-18
(50 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
ORTHO TECHNOLOGY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K051751Device Name
EQUA-PULL SAFETY RELEASE MODULE
Manufacturer
ORTHO TECHNOLOGY
Date Cleared
2005-07-22
(23 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Applicant Name (Manufacturer) :
ORTHO TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.
Device Description
Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety.
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K Number
K000358Device Name
MULTI ADJUSTABLE FACE MASK
Manufacturer
ORTHO TECHNOLOGY
Date Cleared
2000-06-09
(126 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Applicant Name (Manufacturer) :
ORTHO TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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