Search Results
Found 13 results
510(k) Data Aggregation
K Number
K022641Device Name
TOKUYAMA REBASE II
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
2002-10-02
(55 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For relining denture surfaces, to repair a fractured denture, or to form a new denture base.
Device Description
The product is a chairside denture relining material for relining, repairing and rebasing removable dentures. It is substantially equivalent to the company's Tokuso Rebase (K896981). The product is offered in two versions of differing in curing time; i.e., Fast and Normal. The product complies with ADAS No. 17 and has been approved for marketing by the Japanese Ministry of Health and Welfare.
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K Number
K011854Device Name
TOKUYAMA M-BOND
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
2001-09-04
(83 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a dental cement for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses.
Device Description
The product is a self cured adhesive resin cement.
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K Number
K011685Device Name
BISTITE II DC
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
2001-07-31
(61 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a dental cement in various applications, including luting, repair of fractured bridge resins, cementation of adhesive bridge prostheses and CR core posts.
Device Description
The product is a dental cement which can be either light cured or self cured.
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K Number
K010267Device Name
PALFIQUE ESTELITE LV CLEAR
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
2001-02-27
(29 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002863Device Name
PALFIQUE ESTELITE LV
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
2001-01-04
(113 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993917Device Name
TOKUYAMA ONE-UP-BOND F
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
2000-02-02
(77 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.
Device Description
The product is a resin tooth bonding agent for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth and for sealing of exposed cervical dentin and root surfaces.
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K Number
K991711Device Name
BISTITE II SC
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
1999-07-07
(49 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.
Device Description
The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.
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K Number
K982537Device Name
TOKUYAMA SOFRELINER
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
1998-08-24
(34 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a denture reliner
Device Description
The product is a denture relining resin material for use in relining the tissue contact surface of dentures. It is not intended for over-the-counter (OTC) use. It contains materials that are common in dental use and pose no health hazard when used according to directions.
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K Number
K980054Device Name
PALFIQUE ESTELITE
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
1998-04-27
(111 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in dental procedures as a resin filling material
Device Description
The product is a tooth shade resin material for use in dental restorations. It consists of the company's Tokuyama's Mac Bond II bonding agent and Palfique Estelite Paste.
Mac Bond II is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.
After curing, restoration is completed with Palfique Estelite Paste or other composite resin brands.
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K Number
K980058Device Name
TOKUSO MAC BOND II
Manufacturer
TOKUYAMA AMERICA, INC.
Date Cleared
1998-04-27
(111 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
TOKUYAMA AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth
Device Description
The product is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.
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