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510(k) Data Aggregation

    K Number
    K974231
    Device Name
    POSITION PENTA, POSITION PENTA QUICK
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1998-01-29

    (78 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Position® Penta and Position® Penta Quick are indicated for use for impressions for temporary restorations, preliminary impressions, opposing dentitians and orthodontic models.
    Device Description
    Position® Penta and Position® Penta Quick are slightly modified impression materials. Position® Penta, Position® Penta Quick and Dimension® Penta H are all composed of a base paste and catalyst. Position® Penta, Position® Penta Quick and Dimension® Penta H have the same catalyst composition except for use of a pigment identified as an alternative in the Dimension® Penta 510(k). The base paste composition of the products are similar, with the exception of: (1) variations of ingredient amounts; (2) use in Position® Penta and Position® Penta Quick of a new form/chemical structure of a previously used ingredient (silyl polyethylene oxides); and (3) use of new pigments identified as alternatives in the Dimension® Penta 510(k).
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    K Number
    K973513
    Device Name
    SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1997-12-22

    (96 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sinfony® system is indicated for use as a light-curing composite veneer material for: - full and partial coverage of: - fixed crown and bridgework . - telescopic and conical crowns . - precision attachments - implant superstructures . - adhesive bridgework . - laminate veneers . - o individualizing denture teeth - individualizing long-term temporary restorations .
    Device Description
    light-curing composite veneer material
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    K Number
    K973262
    Device Name
    KETAC-FIL APLICAP PLUS
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1997-11-17

    (80 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ketac-Fil® Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.
    Device Description
    Ketac-Fil® Aplicap® Plus is a modified glass ionomer cement material. Modifications have been made to the following ESPE 510(k)s for glass ionomer cement material: (1) Photac-Fil® Aplicap® (K925027); and (2) Ketac-Molar® Aplicap® (K960954), to create a slightly modified product with two new pigments.
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    K Number
    K972892
    Device Name
    CAVIT-LC
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1997-10-02

    (58 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary fillings for inlay and onlay preparations . Temporary fillings of cavities ● Temporary filling of implant sites ● Relining of prefabricated temporary crowns and bridges .
    Device Description
    light-curing temporary filling material, tradenamed Cavit®-LC
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    K Number
    K963735
    Device Name
    COJET SYSTEM
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1996-11-27

    (71 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoJet™-System's intraoral adhesive restoration repair and adhesive cementation uses include: - adhesive repair of defects in porcelain - adhesive repair of defects in porcelain with exposed metal - - adhesive repair of defects in composite - - adhesive repair of defects in composite with exposed metal - conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc. - conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.
    Device Description
    4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The components are CoJet™-Sand, a silane coupling agent, a bonding material, and an Opaquer.
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    K Number
    K963737
    Device Name
    HYCEM APLICAP
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1996-11-15

    (59 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.
    Device Description
    compomer luting cement, tradenamed Hycem® Aplicap®
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    K Number
    K962428
    Device Name
    EBS (ESPE BONDING SYSTEM)
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1996-09-12

    (80 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    intended to bond composite materials to the tooth structure
    Device Description
    3-component resin tooth bonding system, tradenamed EBS® (ESPE Bonding System). The EBS® System is intended to bond composite materials to the tooth structure, and is composed of an etching gel, primer and bonding agent.
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    K Number
    K962440
    Device Name
    PERTAC II/PERTAC II APLITIP
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1996-09-11

    (79 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.
    Device Description
    modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials
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    K Number
    K962442
    Device Name
    HYTAC APLITIP/HYTAC OSB
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1996-09-11

    (79 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.
    Device Description
    Hytac® Aplitip® is a compomer filling material. Hytac® OSB is a light cured bonding agent.
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    K Number
    K960954
    Device Name
    KETAC-MOLAR APLICAP
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1996-05-16

    (66 days)

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

    **ESPE GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.
    Device Description
    slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar Aplicap®. The reason for this modification is to provide for an improved compressive strength.
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