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510(k) Data Aggregation

    K Number
    K182118
    Device Name
    armor LC
    Manufacturer
    Mavrik Dental Systems Ltd
    Date Cleared
    2019-05-03

    (270 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
    Device Description
    armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.
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    K Number
    K151945
    Device Name
    Triumph Resin Dam
    Manufacturer
    DENALI CORPORATION
    Date Cleared
    2016-02-18

    (219 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.
    Device Description
    Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.
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    K Number
    K050318
    Device Name
    BARI-KAD PACKING DEVICE
    Manufacturer
    BIOENVELOP AGRO, INC.
    Date Cleared
    2005-03-04

    (23 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bari-Kad™ is a device intended to protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening.
    Device Description
    Bari-Kad™ Packing Device
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    K Number
    K043301
    Device Name
    GC TION GINGIVAL PROTECTOR
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2005-01-25

    (56 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.
    Device Description
    Not Found
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    K Number
    K040797
    Device Name
    BRITESMILE MASKING CREAM
    Manufacturer
    BRITESMILE, INC.
    Date Cleared
    2004-04-02

    (4 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.
    Device Description
    The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
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    K Number
    K022522
    Device Name
    PULPDENT PUTTY DAM
    Manufacturer
    PULPDENT CORPORATION
    Date Cleared
    2002-09-26

    (58 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
    Device Description
    PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.
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    K Number
    K021524
    Device Name
    LIGHT CURE DENTAL DAM
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2002-07-19

    (70 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prime-Dent Light Cure Soft Dental Dam is for soft tissue isolation and molsture prevention/barrier.
    Device Description
    Not Found
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    K Number
    K021613
    Device Name
    NIVEOUS LIQUID DAM
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2002-06-20

    (35 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.
    Device Description
    Niveous Liquid Dam is a light-cured resin used for soft tissue isolation/protection during teeth whitening procedures. The material is dispensed from a syringe into the gingival crest just shy of the tooth structure. The resin is light-cured (polymerized) on the soft tissue by exposure for 20 seconds per section of material.
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    K Number
    K010935
    Device Name
    BRITESMILE BARRIER MATERIAL
    Manufacturer
    BRITESMILE, INC.
    Date Cleared
    2001-09-05

    (161 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983227
    Device Name
    POWER BLOCK
    Manufacturer
    KREATIV, INC.
    Date Cleared
    1998-12-11

    (87 days)

    Product Code
    EIE, DAT
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PowerBlock is a white, light reflective, paint on dam which, when light cured, will form a semi-plastic barrier which protects gingival tissue.
    Device Description
    PowerBlock is a white, light reflective, paint on dam.
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