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510(k) Data Aggregation

    K Number
    K020499
    Device Name
    BOND-3 ADHESIVE
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2002-04-22

    (67 days)

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

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bond-3 Adhesive is used for the adhesion of tooth (dentin and enamel) to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
    Device Description
    Bond-3 Adhesive and Dentin Conditioning Adhesive System (Bond-1) K936222 contain the same materials. However, Bond-3 Adhesive Contains additional Methacryl-POSS for added improvements. Safety and effectiveness have not been affected.
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    K Number
    K013543
    Device Name
    BOND-1 C & B
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2002-02-22

    (128 days)

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

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359. We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.
    Device Description
    Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359. We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.
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    K Number
    K013542
    Device Name
    DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2002-02-14

    (120 days)

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

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel. We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.
    Device Description
    Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel. We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Dentin Conditioning and Adhesive System, allows the Bond-1 C&B to cure with or without the use of light.
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    K Number
    K012231
    Device Name
    AVANTE MICRO CRYSTAL SYSTEM
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2001-08-23

    (38 days)

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

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A vante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations.
    Device Description
    Avante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations. The composition of Avante Porcelain is similar to that of Synspar Porcelain, K910303. The composition of Available of Avante was adjusted in Avante Porcelain to result in a lower firing temperature compared to Synspar. However, the actual list of chemical compounds present in Avante is similar to that of Synspar.
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    K Number
    K011748
    Device Name
    FIRST FILL R.C.S.
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2001-08-03

    (58 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.
    Device Description
    FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points. The resins used in First Fill RCS are the common dental methacrylate resins.
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    K Number
    K010957
    Device Name
    QUELL DESENSITIZER
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2001-06-25

    (87 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011330
    Device Name
    JP CAST 50
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2001-06-22

    (51 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011331
    Device Name
    JP CAST 40
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2001-06-22

    (51 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011362
    Device Name
    GOLD CORE 73 LS
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2001-05-29

    (26 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010044
    Device Name
    COSMIC
    Manufacturer
    JENERIC/PENTRON, INC.
    Date Cleared
    2001-02-09

    (35 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENERIC/PENTRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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