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510(k) Data Aggregation
K Number
K093059Device Name
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
Manufacturer
Date Cleared
2010-02-04
(127 days)
Product Code
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
CLASSONE ORTHODONTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SeLECT Defense Dental Pit and Fissure Sealant is a BisGMA based light cured resin for the sealing of deciduous teeth and the filling of fissures in primary tooth structure.
Device Description
Not Found
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K Number
K080445Device Name
LION SE ONE STEP ORTHODONTIC ADHESIVE
Manufacturer
Date Cleared
2008-07-16
(148 days)
Product Code
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
CLASSONE ORTHODONTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for bonding brackets to teeth for orthodontic treatment.
Device Description
Lion Se is a one step orthodontic adhesive. It comprises of two major components, i.e., a viscous polymeric resin paste and a watery component called. Activator. The formulation of Lion Se adhesive is identical to the predicate adhesive, except that the Lion Se paste contains 2% of a Selenium compound . This is a modified acrylic monomer which polymerizes & becomes an integral part of the final cured adhesive. The paste is delivered from a syringe, while the activator is dispensed from a squeeze bottle. Besides the paste & the activator, the product kit contains a preloaded syringe of etchant (35% phosphoric acid solution), brushes to apply the activator on the tooth and a stack of mixing pads for easy transfer of the activator.
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K Number
K053379Device Name
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
Manufacturer
Date Cleared
2006-01-25
(51 days)
Product Code
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
CLASSONE ORTHODONTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for bonding brackets to teeth for orthodontic treatment.
Device Description
Reli-On is a one step orthodontic adhesive. It comprises of two major components, i.e., a viscous polymeric resin paste and a watery component called. Activator. The paste is delivered from a syringe, while the activator is dispensed from a squeeze bottle. Besides the paste & the activator, the product kit contains a preloaded syringe of etchant (35% phosphoric acid solution), brushes to apply the activator on the tooth and a stack of mixing pads for easy transfer of the activator.
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