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510(k) Data Aggregation

    K Number
    K160443
    Device Name
    TempoCem Clear
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2016-09-30

    (226 days)

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

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TempoCem Clear is indicated for: - · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays. - · Temporary luting of temporary veneers. - · Temporary or semipermanent luting of implant-borne dental prosthesis.
    Device Description
    TempoCem Clear is a transparent, dual-curing, resin-based dental cement for the temporary or semipermanent cementing of provisional resin-based composite restorations (crowns, bridges, inlays, onlays, veneers) to a tooth and for temporary or semipermanent luting to an implant abutment. The cement consists of two pastes (base and catalyst) packaged in a double-barreled plastic syringe. The pastes are automatically mixed when dispensed through the single-use mixing tips supplied with the device.
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    K Number
    K130580
    Device Name
    RETRACTION PASTE
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2014-02-25

    (357 days)

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

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
    Device Description
    The Retraction Paste is a medium viscosity substance that contains aluminium chloride hexahydrate in a water-based kaolin (clay) inert carrier. The kaolin/water paste provides physical displacement of the gingiva as the material is placed into the sulcus via a manual dispensing syringe. The aluminium chloride hexahydrate component has hygroscopic and astringent properties, which produce a hemostatic/drying effect, and assist in temporarily shrinking the gingival tissue and holding it slightly away (retracted) from the tooth surface, thereby allowing complete access of the impression material.
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    K Number
    K110759
    Device Name
    TEMPOCEM
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2011-06-10

    (84 days)

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

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TempoCem is a dental luting agent indicated for: - . temporary cementation of provisional crowns and bridges - cementing of semi-permanent implants .
    Device Description
    TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.
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    K Number
    K102603
    Device Name
    SA FLOWABLE ADHESIVE
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2010-11-17

    (68 days)

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

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SA Flowable Composite is a self-adhesive, light-curing, flowable composite. SA Flowable Composite applications include: - · Minor restorations of class I (without contact point) - · Underfillings of classes I and II - · Fissure sealing - · Repairs of composite restorations - · Modifications to temporaries and long-term temporaries - Blocking out and filling of undercuts
    Device Description
    SA Flowable Composite is a self-adhesive, light-curing, flowable composite with optimum consistency for the described indications. The radiopaque composite is immediately ready for use because the preparatory steps of etching, priming and bonding are unnecessary. The SA Flowable Composite will be supplied in convenient applicators.
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    K Number
    K101710
    Device Name
    LUXATEMP ULTRA /STAR
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2010-09-28

    (103 days)

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

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. Luxatemp Ultra/Star is intended for the fabrication of: - temporary crowns - bridges - inlays - onlays - long-term temporaries - temporary veneers . Luxatemp Ultra/Star is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.
    Device Description
    Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. Luxatemp Ultra/Star will be supplied in 2 formulations; one is self-curing and the other is dual-cure. The 2 formulations vary slightly in composition to achieve the desired curing properties. The lonnations vary circure and self-cure formulations will be supplied in both Smartmix syringes and Automix cartridges. "Luxatemp Ultra" and "Luxatemp Star" are different trade names for the same material
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    K Number
    K100062
    Device Name
    INFILTRATION KIT
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2010-03-26

    (74 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The Sealant (Infiltrant) is indicated for: - -Sealing of pits and fissures - -Sealing/facing of damaged enamel surfaces - -Covering of caries predilection sites during orthodontic treatment - -Sealing of secondary teeth - -Sealing of deciduous teeth - Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries - Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces) 2. HCI-Etching-Gel is indicated for: - -Etching of enamel
    Device Description
    The DMG USA Infiltration Kit consists of two components, a light curing methacrylate resin-based Sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the Sealant application and as second component an HCl-Etching-Gel. As preliminary step the HCl-Etching-Gel is used for etching of enamel. The Sealant (Infiltrant) is a low viscosity light-curing dental resin, which is a protective coating for tooth surfaces predisposed to caries or on early non-cavitated Jesions. Other uses include sealing of pits and fissures, damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries.
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    K Number
    K093338
    Device Name
    SELF ADHESIVE COMPOSITE LUTING CEMENT
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2010-02-12

    (112 days)

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

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement. The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.
    Device Description
    The Self adhesive composite luting cement is a dental cement that complies with the requirements set forth in the following standards: ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical . devices used in dentistry - Test methods for dental materials; ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials .
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    K Number
    K093587
    Device Name
    DENTAL MERCURY
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2010-01-21

    (63 days)

    Product Code
    ELY
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets, intended to be combined with amalgam alloy for the direct filling of carious lesions or structural defects in teeth.
    Device Description
    Dental Mercury is elemental mercury, supplied as a liquid packaged in sachets.
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    K Number
    K081493
    Device Name
    INFILTRATION KIT
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2008-09-18

    (113 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sealant (Infiltrant) is indicated for: - Sealing of Pit and Fissures . - Sealing/facing of damaged enamel surfaces . - . Covering of caries predilection sites during orthodontic treatment - Sealing of secondary teeth . - Sealing of deciduous teeth . The HCI Etching Gel is indicated for etching of enamel.
    Device Description
    The purposed Infiltration Kit consists of two components, a light curing resin-based sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the sealant application and as second component an HCI-Etching-Gel. The HCI-Etching-Gel is used as a preliminary step for etching of enamel. The proposed sealant (Infiltrant) is designed for use in sealing the enamel pits and fissures of teeth.
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    K Number
    K080480
    Device Name
    NANOCOMPOSITE RESTORATIVE KIT
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2008-05-30

    (98 days)

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

    DMG USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanocomposite Restorative Kit consists of 2 types of nanocomposite restorative materials with a compatible bonding agent. The specific indications of each kit component are as follows: 1. Nanocomposite is indicated for: - Restorations of all cavity classes - Fabrication of direct inlays, onlays and indirect veneers - Core build-up after tooth preparation with the root canal post - Machinable Composite for Restorations - Indirect Inlays/Onlays 2. Nanocomposite Flowable is indicated for: - Small fillings of cavity classes III, IV and V - Minimally invasive fillings for deciduous teeth (all cavity classes) - Splinting of teeth 3. MDP One Bottle Bond is indicated for: - Bonding resin-based materials (especially light-cure composite / compomer materials) to tooth structure (dentin and enamel)
    Device Description
    The Nanocomposite Restorative Kit consists of 3 materials: Nanocomposite, Nanocomposite Flowable, and MDP One Bottle Bond.
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