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510(k) Data Aggregation

    K Number
    K211721
    Device Name
    PS System
    Manufacturer
    Inter-Med, INC.
    Date Cleared
    2021-12-02

    (181 days)

    Product Code
    NYL
    Regulation Number
    872.4200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
    Device Description
    The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
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    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
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    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
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    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
    K071615
    Device Name
    FIXAFLOSS
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2007-09-21

    (100 days)

    Product Code
    EEF
    Regulation Number
    872.6300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams. The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.
    Device Description
    The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.
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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
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    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
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    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
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    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
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    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
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    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
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    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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