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Found 7 results
510(k) Data Aggregation
K Number
K990314Device Name
MULTI-CURE COMPOSITE CEMENT
Manufacturer
MEDENTAL INTL.
Date Cleared
1999-04-02
(60 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
MEDENTAL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Multi-Cure composite cement is used as a luting cement for veneers, crowns, and bridges for anterior and posterior teeth. Composite restorative materials were developed by Dr. Raphael Bowen working for American Dental Research. The main innovation was Bisphenol A-Glycidyl Methacrylate (Bis-GMA), a dimethacrylate resin with silane coated filler (quartz) particles. These coated particles could bond chemically to the Bis-GMA resin. This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.
Device Description
Multi-Cure Composite Cement. The base paste and catalyst paste when mixed together form an exothermic reaction. When a standard dental curing light in the visible wave-length range is used it will cause the camphorquinone and the liquid "A" dimethylaminoethyl methacrylate to accelerate this reaction.
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K Number
K983018Device Name
ZINC PHOSPHATE CEMENT
Manufacturer
MEDENTAL INTL.
Date Cleared
1998-10-22
(55 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
MEDENTAL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.
Device Description
Zinc Phosphate is the oldest of the cementation agents and thus the one with the longest track record (introduced in 1878). It serves as a standard by which newer systems can be compared. It consists of powder and liguid in two separate bottles. The main ingredients of the powder are zinc oxide and magnesium oxide. The liquid contains phosphoric acid, distilled water, alumina hydrate, and zinc oxide. Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.
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K Number
K982779Device Name
MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1
Manufacturer
MEDENTAL INTL.
Date Cleared
1998-09-30
(54 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
MEDENTAL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.
Device Description
Not Found
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K Number
K982191Device Name
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
Manufacturer
MEDENTAL INTL.
Date Cleared
1998-09-14
(84 days)
Product Code
EBF, DAT
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
MEDENTAL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.
Device Description
Chemical Cure Composite with Enamel Bond
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K Number
K980990Device Name
POLYCARBOXYLATE CEMENT
Manufacturer
MEDENTAL INTL.
Date Cleared
1998-07-31
(136 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
MEDENTAL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a chemically activated adhesive that is used in the cementation of inlays, crowns, bridges, facings, and orthodontic brackets. It may also be used as a cavity lining under all restorative materials or following root canal treatment. This adhesive is also used in the cementation of temporary fillings and fillings in deciduous teeth.
Device Description
Polycarboxylate Cement
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K Number
K973919Device Name
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
Manufacturer
MEDENTAL INTL.
Date Cleared
1997-12-16
(62 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
MEDENTAL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.
Device Description
Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)
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K Number
K973541Device Name
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
Manufacturer
MEDENTAL INTL.
Date Cleared
1997-11-25
(68 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
MEDENTAL INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.
Device Description
Chemically Activated Pit and Fissure Sealant
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