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510(k) Data Aggregation

    K Number
    K203760
    Device Name
    Tokuyama Universal Bond II
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2021-05-25

    (153 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOKUYAMA UNIVERSAL BOND II is indicated for: - Direct anterior and posterior restorations with light-curing, dual-curing, and self-curing composite materials - Intraoral repair of composite restorations, porcelain fused to metal, metal, and all-ceramic restorations without an additional primer - Cementation of indirect restorations and veneers when combined with light-cure, dual-cure, and self-curing resin cements - Bonding of core build-ups made of core build-up materials - Bonding of denture resin to metal base, clasp or attachment - Repair of denture with metal base, clasp or attachment - Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns
    Device Description
    The TOKUYAMA UNIVERSAL BOND II device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch and total-etch techniques. As a universal adhesive, TOKUYAMA UNIVERSAL BOND II has been designed to be fully compatible with light-cured, self-cured and dual-cured composite materials. TOKUYAMA UNIVERSAL BOND II contains phosphoric acid monomer, bisphenol A di(2-hydroxy propoxy) dimethacrylate (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), 2-Hydroxyethyl methacrylate (HEMA), MTU-6 (thiouracil monomer), silane coupling agent, peroxide, borate catalyst, acetone, ethanol and purified water. Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrated by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends. The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler. The TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use.
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    K Number
    K203598
    Device Name
    Omnichroma Flow Bulk
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2021-02-03

    (56 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tooth shade resin material in dental procedures such as: - Direct anterior and posterior restorations - Cavity base or liner - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite
    Device Description
    The OMNICHROMA FLOW BULK is a low viscosity, light-cured, radiopaque composite tooth shade resin material for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA FLOW BULK device is a single shade material. Direct placement of the OMNICHROMA FLOW BULK device into a prepared cavity allows for easily handling. The OMNICHROMA FLOW BULK device is a flowable material which can be placed in 3.5mm increments. The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber. OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.
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    K Number
    K193537
    Device Name
    Omnichroma Flow
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2020-08-19

    (243 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/ composite.
    Device Description
    The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling. OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure. The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use. The OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.
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    K Number
    K190940
    Device Name
    Tokuyama Rebase III
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2019-10-04

    (177 days)

    Product Code
    EBI, CLA
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOKUYAMA REBASE III device is for relining dentures and extension of denture borders.
    Device Description
    The TOKUYAMA REBASE III device is an acrylic resin used for chairside hard denture linings and extension of denture borders. The powder contains poly(ethyl methacrylate) and benzoyl peroxide. The liquid contains methacrylate monomer. The REBASE adhesive contains ethyl acetate, acetone and methacrylate polymer. The REBASE adhesive is used solely for bonding to acrylic surfaces, and cannot be used to bond nylon, metal, and silicone surfaces, etc. The device is composed of both a powder and liquid that is cured by chemical polymerization. The powder is packaged in a plastic bottle, and the liquid is packaged in a glass bottle. A group of polymerization agents of the device is contained in the powder and liguid separately to avoid the reaction during storage, and the polymerization reaction starts by mixing the powder and liquid. The device is cured by polymerization of methacrylic monomers contained in the liquid. The TOKUYAMA REBASE III kit contains powder, liquid, REBASE adhesive, TOKUSO RESIN HARDENER II, and other accessories, namely, a measuring cup, dropper, rubber cup, spatula, drip nozzle, drip cup, brush, and spoon. The device does not come sterile and is not intended to be sterilized prior to use. The powder comes in "fast" and "normal" depending on the desired setting time, and in three shades designated as Light Pink, Pink, and Live Pink.
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    K Number
    K180613
    Device Name
    Estelite Universal Flow
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2018-07-12

    (126 days)

    Product Code
    EBF, EST
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTELITE UNIVERSAL FLOW device is indicated for use as a tooth shade resin material in dental procedures, such as: - Direct anterior and posterior restorations - Cavity base or liner - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite
    Device Description
    The ESTELITE UNIVERSAL FLOW tooth shade resin device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations. The device incorporates Radical-Amplified Photopolymerization initiator technology (RAP technology), which facilitates a shortened light curing time and ample working time. ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm. The device does not come sterilized and is not intended to be sterilized prior to use.
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    K Number
    K173275
    Device Name
    OMNICHROMA
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2018-02-27

    (138 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tooth shade resin material in dental procedures, such as: - Direct anterior and posterior restorations - Direct bonded composite veneer - Diastema closure - Repair of porcelain/composite
    Device Description
    The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade. The device does not come sterilized and is not intended to be sterilized prior to use.
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    K Number
    K171226
    Device Name
    TOKUYAMA UNIVERSAL BOND
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2017-11-28

    (216 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOKUYAMA UNIVERSAL BOND is indicated for: - Direct anterior and posterior restorations with light-curing, and self-curing composite materials - Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without an additional primer - Cementation of indirect restorations and veners when combined with light-cure, and self-curing resin cements - Bonding of core build-ups made of core build-up materials - Bonding of denture resin to metal base, clasp or attachment - Repair of denture with metal base, clasp or attachment - Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns
    Device Description
    The TOKUYAMA UNIVERSAL BOND device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch, and total-etch techniques. The TOKUYAMA UNIVERSAL BOND device is fully compatible with light-cured. self-cured, and dual-cured composite materials. Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrate by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends. The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.
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    K Number
    K170549
    Device Name
    TOKUYAMA CUREGRACE
    Manufacturer
    Tokuyama Dental Corporation
    Date Cleared
    2017-07-05

    (131 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tokuyama Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOKUYAMA CUREGRACE device is an acrylic resin used in a variety of dental applications such as: - Temporary inlay, crowns and bridges - Repair of broken or cracked dentures - Denture border extension - Replacement of lost denture teeth - Adjustment of the occlusal height of resin teeth
    Device Description
    The TOKUYAMA CUREGRACE device is a self-curing acrylic dental resin used for denture relining, repairing, or rebasing and for temporary crowns and bridges. The device is composed of powder and liquid that is cured by chemical polymerization. The powder is packaged in a plastic bottle, and the liquid is packaged in a glass bottle. The powder comes in four shades designated as A2, A3, Pink, and Live Pink. The device does not come sterile and is not intended to be sterilized prior to use. The TOKUYAMA CUREGRACE device comes with a measuring cup for measuring the powder component and a dropper for dispensing the liquid component.
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    K Number
    K161353
    Device Name
    ESTELITE BULK FILL Flow
    Manufacturer
    TOKUYAMA DENTAL CORPORATION
    Date Cleared
    2017-04-03

    (322 days)

    Product Code
    EBF, EST
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA DENTAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tooth shade resin material in dental procedures, such as: - Direct anterior and posterior restorations - Cavity lining - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite
    Device Description
    ESTELITE BULK FILL Flow is a low viscosity, light cured radiopaque composite dental tooth shade resin material. This low stress flowable material can be placed in 4 mm increments. The device incorporates Radical-Amplified Photopolymerization (RAP) initiator technology, which facilitates a shortened light curing time and ample working time. The device comes in five shades, namely U (Universal), A1, A2, A3, and B1.
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    K Number
    K150727
    Device Name
    ESTECEM
    Manufacturer
    TOKUYAMA DENTAL CORPORATION
    Date Cleared
    2015-06-17

    (89 days)

    Product Code
    EMA, REG
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA DENTAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECEM device is an adhesive resin cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for: - Repair of fractured porcelain fused to metal crowns and all ceramic restorations - Cementation of veneers - Cementation of adhesion bridges - Cementation of metal or resin cores, metal or glass-fiber posts
    Device Description
    The ESTECEM device is a dual-cure (light and/or self-cure), radiopaque, adhesive resin cement system with excellent handling, esthetic and adhesive properties to teeth and all prosthetic materials. The main components of the ESTECEM device are (1) the paste (A/B) and (2) primer kit. The paste and primer are packaged in plastic syringes and plastic bottles, respectively. The device also comes with a mixing dish (dispensing well), disposable applicator, and cement mixing tip. The paste is dispensed in an automix syringe and is available in various shades (universal, clear, brown and white-opaque). The primer kit components consist of ESTELINK (bond A/bond B) and Tokuyama Universal Primer (A/B). The ESTELINK bond promotes the adhesion of the paste to the tooth structure. The Tokuyama Universal Primer enhances the adhesion of the paste to prosthetic materials. The ESTECEM device does not come sterilized and is not intended to be sterilized prior to use.
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