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510(k) Data Aggregation

    K Number
    K213201
    Device Name
    DeltaFil, DeltaFil Conditioner
    Date Cleared
    2022-06-01

    (245 days)

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

    DMG Chemisch-Pharmazeutische Fabrik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DeltaFil (in capsule) is used for geriative filling procedures. The procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material. DeltaFil Conditioner: - Treatment of the smear layer - Conditioning of the cavity
    Device Description
    DeltaFil consists of a radiopaque glass ionomer restorative material supplied in capsule form (DeltaFil in capsule), and a compatible tooth conditioner (DeltaFil Conditioner). DeltaFil Conditioner and DeltaFil (in capsule) are used together for the creation of permanent or temporary dental restorations as described in the device labelling. DeltaFil is available in Vita shades A1, A2, A3, A3.5, and A4. DeltaFil (in capsule) is a two-part powder/liguid glass polyalkenoate restorative cement as defined in ISO 9917-1:2006 Dentistry - Water-Based Cements - Part 1: powder/liquid acid-base cements. The powder and liquid components are supplied in the correct mixing ratio in disposable "Applicap" capsules for use with the DMG Applicap Dispenser. DeltaFil Conditioner is a 10% aqueous polyacrylic acid solution, which is applied to the prepared tooth surface prior to placement of the mixed DeltaFil (in capsule) material. DeltaFil Conditioner improves the adhesive bond between the tooth tissue and the restorative cement material by treating the smear layer and conditioning the prepared cavity.
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    K Number
    K183337
    Device Name
    LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2
    Date Cleared
    2019-05-29

    (177 days)

    Product Code
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG Chemisch-Pharmazeutische Fabrik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LuxaCrown is a self-curing composite for the fabrication of semi-permanent crowns and bridges. The material is mixed automatically. Specifically: Crown restorations: For restoration of the anatomical form in order to provide durable protection for the remaining tooth; In order to restore chewing function; For esthetic corrections. Bridge restorations: In order to restore chewing function; For esthetic corrections.
    Device Description
    LuxaCrown is a bis-acrylic resin-based self-curing composite for the fabrication of semipermanent crowns and bridges. LuxaCrown is available in a range of shades to ensure an aesthetically-pleasing restoration. LuxaCrown is a non-sterile device intended for use by licensed dental professionals. Because LuxaCrown is intended for the fabrication of semi-permanent dental restorations, it may remain in the oral cavity for more than 30 days. LuxaCrown is supplied in dual-barreled syringes for use with the DMG Automix selfmixing dispenser and Automix Tips, which were previously cleared in K101710 (DMG LuxaTemp Ultra), K013674 (DMG LuxaTemp) and K924830 (DMG LuxaTemp Automix).
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