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510(k) Data Aggregation

    K Number
    K052699
    Device Name
    VERSA-LINK PORCELAIN BONDING SYSTEM
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2005-11-16

    (49 days)

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

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Versa-Link Porcelain Bonding System is indicated for the adhesive cementation/bonding of all-ceramic dental restorations (veneers, inlays, onlays and crowns) composed of feldspathic porcelain, pressed porcelain and in-office machined ceramics. A secondary indication is for the adhesive repair of fractured or damaged metal-ceramic units intraorally.
    Device Description
    Not Found
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    K Number
    K052409
    Device Name
    SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2005-10-20

    (49 days)

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

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silgimix™ is indicated for use as a dental impression material. The material is intended primarily for taking impressions for study models, orthodontic models, counter impressions, partial denture impressions and temporary crown fabrication.
    Device Description
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    K Number
    K043054
    Device Name
    GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2005-02-18

    (105 days)

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

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sultan Genie Magic Mix™ Ultra Hydrophilic Impression Material is intended for use as a dental impression material, compatible with all techniques including dual-phase, monophase and dual impression techniques. The material is dispensed from an automatic mixing machine system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
    Device Description
    Not Found
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    K Number
    K030414
    Device Name
    GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2003-04-09

    (61 days)

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

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
    Device Description
    Not Found
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    K Number
    K020612
    Device Name
    SULTAN SPOROX TEST VIAL, MODEL 75195
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2002-05-07

    (71 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization.
    Device Description
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    K Number
    K002843
    Device Name
    SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    2000-11-15

    (64 days)

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

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991509
    Device Name
    PRO-PORTION CLEANER/DISINFECTANT
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    1999-07-14

    (75 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required. This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.
    Device Description
    Pro-Portion is a broad spectrum, multi-purpose ready to use, effective cleaner and disinfectant for use on the surfaces of inanimate objects. Pro-portion will efficiently clean and disinfect, when used as directed, such items as laminated counter tops, dental units, dental instruments, lights, and other inanimate surfaces, including those made of plastics (such as: polycarbonate, polyvinylchloride, polypropylene and polystyrene), nonporous vinyl and upholstery, stainless steel, painted surfaces, Plexiglas, glass, and other hard non-porous surfaces.
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    K Number
    K971138
    Device Name
    DINABASE (TM)
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    1997-07-21

    (115 days)

    Product Code
    EBI, DAT
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULTAN CHEMISTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.
    Device Description
    Not Found
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