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510(k) Data Aggregation

    K Number
    K161630
    Device Name
    Provicol QM Plus
    Manufacturer
    VOCO GMBH
    Date Cleared
    2016-09-15

    (94 days)

    Product Code
    EMB
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provicol QM Plus is intended for use as: - · Temporary cementation of provisional restorations (crowns, bridges, inlays and onlays) - . Temporary cementation of definitive restorations (crowns, bridges, inlays and onlays)
    Device Description
    Not Found
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    K Number
    K120695
    Device Name
    DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
    Manufacturer
    DENTIST IN A BOX PTY. LTD
    Date Cleared
    2012-06-12

    (97 days)

    Product Code
    EMB, TBD
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit provides immediate, temporary relief from common dental problems, accidents and trauma until a dentist can be seen. For use by trained professionals. For temporary relief from a lost filling, chipped tooth, or irritation by orthodontic wire or denture clasp or for temporary stabilization of a loosened or knocked out permanent tooth. Used by persons in remote areas such as during military field service when access to a dentist or dental equipment and facilities are not available for an extended period of time and effective treatment is necessary to prevent discomfort or delay in treatment may aggravate the injury.
    Device Description
    Dentist In A Box intends to assemble U.S. FDA regulatory cleared and/or exempt devices into a convenience kit for the U.S. market. The kit components are either (1) legally marketed pre-Amendments devices, (2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulation(s) and the limitation of exemptions for Section 510(k) of the act (e.g., 862.9), or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended (i.e., not claiming or causing a new use for the component(s)). The components are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their pre-Amendments, exemption, or premarket notification criteria and status. Components: Hand-held mouth mirror Sterile Cotton-tipped swabs Temporary filling material Tooth splinting material Sterile unbuffered Saline Solution 0.9%, 5ml unit dose Sterile Disposable gloves
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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?
    Product Code :

    EMB

    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
    K073539
    Device Name
    PROVISA CEM
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2008-01-31

    (45 days)

    Product Code
    EMB, EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PROVISA CEM is intended for the cementation of temporary crowns and bridges. PROVISA CEM is free of eugenol. After its removal, it will also not inhibit the polymerisation of a composite cement or composite filling material.
    Device Description
    PROVISA CEM is a dental cement and is particularly intended for the cementation of temporary crowns and bridges. Such a temporary prosthesis is a necessity for the patient in the period between the preparation of the tooth (or teeth) stump, followed by the impression taking, and the placement and cementation of the final prosthesis. During this period of one week or more, the prepared tooth stump has to be protected against any damage. But also the occlusal relationship of the tooth stump versus neighbouring and antagonist teeth has to be kept unchanged in order to prevent articulation problems upon placing the final prosthesis. A temporary cement should offer sufficient retentive force to keep the temporary prosthesis in situ during the intervening week(s), but at the same time it should enable the dentist to take the prosthesis off without damaging the tooth stump and with no discomfort for the patient. PROVISA CEM is presented in the form of two pastes: a white paste, containing zincand magnesium oxide as the reactive components and a yellow paste, containing fatty acid dimer as the reactive component. Upon mixing homogeneously, controlled by a uniform light yellow colour, a smooth paste with the correct consistency is formed, that can be pressed into a thin, but sufficiently strong cement layer. Through a reaction between the metallic oxides and the fatty acid dimer, a chelatenetwork is formed, that makes the paste harden. The resulting cement is stable and strong enough but not too strong.
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    K Number
    K020158
    Device Name
    NON-EUGENOL TEMPORARY CEMENT
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2002-03-07

    (49 days)

    Product Code
    EMB, EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for cementing temporary crowns, bridges, and other restorations as well as for trial cementing permanent restorations
    Device Description
    Not Found
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