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510(k) Data Aggregation

    K Number
    K121915
    Device Name
    BRIGHT RESTORATIVE MATERIALS
    Manufacturer
    Date Cleared
    2012-09-28

    (88 days)

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

    DMP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BRIGHT Restorative Materials, to include: - NANOCERAM BRIGHT FLOW . - BRIGHT FLOW CORE . - BRIGHT HEAVY CORE . - BRIGHT LIGHT . - BRIGHT LIGHT FLOW . - · BRIGHT POSTERIOR Indications for Use: NANOCERAM - BRIGHT FLOW Indications for use: - · Fillings of minimally invasive cavities of all classes - Fillings of small class I cavities . - Fillings of class II-V cavities including V-shaped defects and cervical caries - Extended fissure sealing - Cavity lining as the first layer for Class I and II restorations - Splinting of mobile teeth ● - Blocking out of undercuts - Small restorations of all types - Repair of composite restorations and ceramic veneers BRIGHT FLOW CORE - BRIGHT HEAVY CORE Indications for use: - Core build up of vital and non-vital teeth . - Post cementation BRIGHT LIGHT - BRIGHT LIGHT FLOW BRIGHT LIGHT Indications for use: - Class I-V restorations . - Reconstruction of affected anterior teeth ● - Veneering of discoloured anterior teeth . - Splinting of mobile teeth - Repair of composite and ceramic veneers BRIGHT LIGHT FLOW Indications for use: - · Fillings of minimally invasive cavities of all classes - Fillings of class II-V cavities including V-shaped defects and cervical caries . - Extended fissure sealing . - Splinting of mobile teeth . - Blocking out of undercuts . - Small restorations of all types . - Repair of composite restorations and ceramic veneers BRIGHT POSTERIOR Indications for use: - · Direct posterior restorations (Class I and II), including occlusal surfaces - Core build ups ● - Splinting of mobile teeth
    Device Description
    Not Found
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    K Number
    K102836
    Device Name
    BONASIL A+ IMPRESSION MATERIALS
    Manufacturer
    Date Cleared
    2011-01-13

    (106 days)

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

    DMP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bonasil A* Impression Materials are intended to: - be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; - provide models for study and for production of restorative prosthetics devices; Indications for use: - BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Crown/bridge work - Inlays, onlays - BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Crown/bridge work - Inlays, onlays - BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for: - Single step putty/wash technique - Functional peripheries - Crown/bridge work - Inlays, onlays - BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Reline impressions - Crown/bridge work - Inlays, onlays - BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Reline impressions - Crown/bridge work - Inlays, onlays - BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for: - Making accurate occlusal registrations - Standards bite registrations in the end bite position - Key material for needle point registration - Production of small model segments - An optical registration of occlusal data for CAD/CAM/CIM systems - BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for: - Preliminary impressions - Anatomic models - Fabricating temporary crowns and bridges - Opposing dentition - Fabricating simple removable prosthetic restorations - Orthodontic work - Case study models
    Device Description
    The Bonasil A* Impression Materials are intended to: - be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; - provide models for study and for production of restorative prosthetics devices; Indications for use: - BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Crown/bridge work - Inlays, onlays - BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Crown/bridge work - Inlays, onlays - BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for: - Single step putty/wash technique - Functional peripheries - Crown/bridge work - Inlays, onlays - BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Reline impressions - Crown/bridge work - Inlays, onlays - BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for: - Two step putty/wash technique - Single step putty/wash technique - Functional peripheries - Reline impressions - Crown/bridge work - Inlays, onlays - BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for: - Making accurate occlusal registrations - Standards bite registrations in the end bite position - Key material for needle point registration - Production of small model segments - An optical registration of occlusal data for CAD/CAM/CIM systems - BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for: - Preliminary impressions - Anatomic models - Fabricating temporary crowns and bridges - Opposing dentition - Fabricating simple removable prosthetic restorations - Orthodontic work - Case study models
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    K Number
    K102252
    Device Name
    DMP PIT & FISSURE SEALANT
    Manufacturer
    Date Cleared
    2010-12-03

    (115 days)

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

    DMP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Pits and fissures of molars and premolars - Fissures on the lingual sides of anterior teeth
    Device Description
    Not Found
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    K Number
    K102254
    Device Name
    DMP SINGLE BONDING
    Manufacturer
    Date Cleared
    2010-11-23

    (105 days)

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

    DMP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - · Bonding agent (bonding liquid) for adhesive restorations - · Transparent sealant for fissures and restorations - Bonding layer for the repair of resin-, crown-, or bridge works .
    Device Description
    Not Found
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    K Number
    K102255
    Device Name
    DMP ETCHING GEL
    Manufacturer
    Date Cleared
    2010-11-23

    (105 days)

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

    DMP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Etching the enamel and dentin for adhesive restorations
    Device Description
    Not Found
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    K Number
    K102257
    Device Name
    NANOCERAM- BRIGHT
    Manufacturer
    Date Cleared
    2010-11-19

    (101 days)

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

    DMP LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Anterior restorations (Class III, IV) - Posterior restorations (Class I, II) - Class V restorations (Cervical caries, root erosion, wedge shaped defects) - Veneering of discolored anterior teeth - Splinting of mobile teeth . : . - Repair of composite and ceramic veneers
    Device Description
    Not Found
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