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510(k) Data Aggregation

    K Number
    K103585
    Device Name
    BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2011-03-04

    (87 days)

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

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.
    Device Description
    AEGIS Liner & Restorative Material w/ACP
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    K Number
    K100731
    Device Name
    BOSWORTH AIR POLISHER
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2010-12-03

    (263 days)

    Product Code
    EFB, BOS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional.It is a prescription device The packaging contains the following statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist. "
    Device Description
    The Air Polisher is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water spray is generated. This spray can be directed on the tooth surface to clean and polish the tooth.
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    K Number
    K061611
    Device Name
    BOSWORTH DENTIN RESIN
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2006-09-11

    (94 days)

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

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bosworth Dentin Resin is used with either an acid etchant or a self-etch bond to provide a light-cure bond for bonding dental resin composites, resin luting cements, orthodontic adhesives and resin sealalnts to tooth structures - tooth enamel and dentin. It is indicated for use with light-cure, self-cure (autopolymerizable) and dual-cure (light-cure and/or self-cure combination) resin based materials. The Bosworth Dentin Resin can also be used with the same light-curable, selfcurable and dual-curable resin based materials to bond to ceramic and metal surfaces including dental amalgam.
    Device Description
    Not Found
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    K Number
    K051224
    Device Name
    BOSWORTH SEAL
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2005-07-28

    (77 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bosworth Seal is a light-activated dental sealant for sealing pits and fissures of anterior and posterior teeth. The Bosworth Seal is a surface glaze and is used for denture and orthodontic retention systems.
    Device Description
    Not Found
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    K Number
    K043170
    Device Name
    BOSWORTH BOND
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2005-02-25

    (101 days)

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

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond. Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.
    Device Description
    Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond. Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.
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    K Number
    K040547
    Device Name
    AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2004-03-19

    (17 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket. The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands. The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.
    Device Description
    Not Found
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    K Number
    K040548
    Device Name
    AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2004-03-19

    (17 days)

    Product Code
    DYH, DYI
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light. The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive). The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, vencer, inlay,only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adlesive.
    Device Description
    Not Found
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    K Number
    K033751
    Device Name
    AEGIS PIT & FISSURE SEALANT WITH ACP
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2004-02-05

    (66 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aegis Pit & Fissure Sealant with ACP is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Aegis Pit & Fissure Sealant with ACP is available in opaque and tinted shades, when different shades are indicated for use.
    Device Description
    Not Found
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    K Number
    K031439
    Device Name
    ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2003-10-02

    (149 days)

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

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Alginate Impression Material III (Fast & Regular Set) with water is used as dental impression material.
    Device Description
    Not Found
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    K Number
    K031811
    Device Name
    PIT & FISSURE SEALANT WITH FLUORIDE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    2003-09-04

    (84 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARRY J. BOSWORTH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades, when differen! shades are indicated for use.
    Device Description
    Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades.
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