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510(k) Data Aggregation

    K Number
    K140602
    Device Name
    FLASH PENTA MB QUICK, FLASH MB QUICK
    Manufacturer
    3M ESPE AG
    Date Cleared
    2014-06-05

    (87 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M ESPE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All types of impressions, e.g .: · Crown, bridge, inlay, and onlay preparations · Implants · Orthodontic impressions
    Device Description
    Flash Penta™ MB Quick and Flash MB Quick are addition type silicone impression materials of medium consistency. Flash Penta MB Quick is mixed in the Pentamix mixing device, while Flash MB Quick can be applied directly using the Garant™ dispenser. Both products are used in mono-phase technique and in one-step technique.
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    K Number
    K133400
    Device Name
    FLASH BITE
    Manufacturer
    3M ESPE AG
    Date Cleared
    2014-03-06

    (120 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M ESPE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bite registration.
    Device Description
    Flash Bite is classified as impression materials (21 C.F.R. § 872.3660) because it is a devices intended to reproduce the structure of a patient's teeth. Flash Bite is a two component (base paste/catalyst) vinyl polysiloxane bite registration material designed to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 1:1 (by volume).
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    K Number
    K120011
    Device Name
    HEISENBERG EFFECT SHADES
    Manufacturer
    3M ESPE AG
    Date Cleared
    2012-01-13

    (10 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M ESPE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia restorations after basic dyeing using Heisenberg Dyeing Liquids.
    Device Description
    Heisenberg Effect Shade is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth restorations after basic dyeing using Heisenberg Dyeing Liquids. Heisenberg Effect Shades will be available in various colors.
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    K Number
    K110508
    Device Name
    SUGLUE-10
    Manufacturer
    3M ESPE AG
    Date Cleared
    2011-06-03

    (101 days)

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

    3M ESPE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) - Final cementing of posts and screws . - Final cementation of all-ceramic, or composite veneers ● - Final cementation of all-ceramic, composite, or metal restorations on implant . abutments
    Device Description
    Suglue-10, manufactured by 3M ESPE, is a dual-curing resin cement supplied in an automix syringe. It is intended to be used for the adhesive cementation of indirect restorations and will be available in various shades. Suglue-10 is intended to be used in combination with an adhesive, e.g. Adhesive EXL 759 (by 3M ESPE). The Adhesive EXL 759 can be used either as a "Total Etch" or "Self-Etch" procedure. The additional etching of the tooth structure increases the adhesive strength of the adhesive even further. Suglue-10 contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 43% by volume; the grain size (D 90%) is about 13 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst.
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    K Number
    K110302
    Device Name
    ADHESIVE EXL-759
    Manufacturer
    3M ESPE AG
    Date Cleared
    2011-05-19

    (106 days)

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

    3M ESPE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - All classes of fillings (according to Black) with light-curing composite or compomer . filling materials - Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of . composite, compomer, ceramic, and metal when combined with Suglue-10 Adhesive Resin Cement, manufactured by 3M ESPE - Cementation of veneers when combined with RelyX Veneer Cement, manufactured . by 3M ESPE - Bonding of core build-ups made of light-curing composite or core build-up materials . - Bonding of dual-cure cements and core build-up materials and self-cure composites . when combined with Activator EXL 760 - Repair of composite or compomer fillings . - Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic . restorations without extra primer - Root surface desensitization . - Sealing of cavities prior to cementation of amalgamate restorations . - Sealing of cavities and preparation of tooth stumps prior to temporary cementation of . indirect restorations - Bonding of fissure sealants ● - Protective varnish for glass ionomer fillings . - Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and . alumina), metal and composite
    Device Description
    Adhesive EXL 759, manufactured by 3M ESPE, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200). Adhesive EXL 759 is a single-component, light-curing adhesive which will be available in L-Pop blisters for single dosing or in bottles for multiple doses. Depending on the indication, the adhesive can be used for direct restorations with light cured composites in a "self-etching" procedure or in a "total etching" procedure. Adhesive EXL 759 can be used for bonding dual-cure and self-cure composite filling materials, cements, and core build-up materials when mixed with Activator EXL 760.
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    K Number
    K111257
    Device Name
    HEISENBERG DYEING LIQUIDS
    Manufacturer
    3M ESPE AG
    Date Cleared
    2011-05-13

    (9 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M ESPE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.
    Device Description
    Heisenberg Dyeing Liquid is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Heisenberg Dyeing Liquid is intended to be used for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth. Heisenberg Dyeing Liquids will be available in various shades which are corresponding to every tooth color.
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    K Number
    K100908
    Device Name
    UNICEM HM
    Manufacturer
    3M ESPE AG DENTAL PRODUCTS
    Date Cleared
    2010-06-22

    (82 days)

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

    3M ESPE AG DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementation of post and screws; Final cementation of ceramic, composite or metal restorations on implant abutments; Cementation of abutments made of Lava™ zirconium oxide ceramic.
    Device Description
    Unicem HM in the Clicker™ dispenser is a dual-curing, self-adhesive resin cement for hand mixing. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70% by weight; the grain size (D 90%) is about 12.5 um. The mixing ratio; based on volume, is 1 part base paste : 1 part catalyst. The cement is available in various shades.
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    K Number
    K100756
    Device Name
    MALTA
    Manufacturer
    3M ESPE AG DENTAL PRODUCTS
    Date Cleared
    2010-06-02

    (77 days)

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

    3M ESPE AG DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementing of posts and screws; Final cementation of all-ceramic, composite, or metal restorations on implant abutments.
    Device Description
    Malta is a dual-curing, self-adhesive resin cement available in an automix syringe. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70 % by weight; the grain size (D 90 %) is about 12.5 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. The two pastes are mixed by a static single use mixer attached to the syringe. Malta is available in various shades.
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    K Number
    K094007
    Device Name
    UNICEM
    Manufacturer
    3M ESPE AG DENTAL PRODUCTS
    Date Cleared
    2010-04-08

    (101 days)

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

    3M ESPE AG DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementation of post and screws Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic
    Device Description
    Unicem Aplicap/Maxicap cements are dual-curing, self-adhesive resin cements available in two single dose delivery systems in capsules (K020256). They are used for the permanent cementation of indirect restorations made of ceramic, composite, or metal, and for posts and screws. Bonding and conditioning of the prepared tooth structure are not necessary with Unicem Aplicap™ and Maxicap™M. Unicem Aplicap™ and Unicem Maxicap™ release fluoride ions, and are available in various shades. Unicem Aplicap™ and Unicem Maxicap™ contain bifunctional (meth)acrylate.
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    K Number
    K093721
    Device Name
    COSP2
    Manufacturer
    3M ESPE AG DENTAL PRODUCTS
    Date Cleared
    2010-02-19

    (79 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    3M ESPE AG DENTAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All indications for displacement of the marginal gingiva and to provide for a dry sulcus when the periodontium is healthy.
    Device Description
    CoSP2, manufactured by 3M ESPE, is a retraction paste for the displacement of marginal gingiva and to provide for a dry sulcus. Any suitable, commonly available dispensers, e.g., the Capsule Applicator, manufactured for 3M ESPE, can be used for application of the retraction paste. The paste is applied directly from the retraction capsule into the sulcus. A CoSP2 retraction capsule may not be used on more than one patient.
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