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510(k) Data Aggregation

    K Number
    K123855
    Device Name
    WATER-FILLED TEETHER
    Manufacturer
    SOLID TOYS IND. LTD.
    Date Cleared
    2013-05-24

    (161 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated to soothe and cool teething babies and help reduce teething pain.
    Device Description
    The proposed Water-filled teether is a simple plastic shaped device which is filled with water. It may be placed in a refrigerator to be cooled and then provided to the teething baby to help sooth any pain from teething. This is an OTC device.
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    K Number
    K110615
    Device Name
    WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
    Manufacturer
    BEBE TOYS MANUFACTORY LTD.
    Date Cleared
    2011-12-02

    (274 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.
    Device Description
    Not Found
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    K Number
    K092025
    Device Name
    FLUID FILLED TEETHER - GEL
    Manufacturer
    KIDS II
    Date Cleared
    2011-01-27

    (570 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All teethers instruct consumer to: . - Clean before use with a damp cloth and mild soap. Air dry. o - o Not dishwasher safe - Freezer safe ◆ Teether acts as an aid in relieving an infant's gums due to teething. .
    Device Description
    Fluid Filled Teether - Gel
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    K Number
    K092781
    Device Name
    MAM TWISTER
    Manufacturer
    MAM INTERNATIONAL AG
    Date Cleared
    2010-06-23

    (286 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.
    Device Description
    Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP <61>, ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec.101: general lead ban - lead in substrate (< 100 ppm), 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPS1A Sec.108 & CA Bill 1108 - Ban on phthalates (DEHP, DBP, DINP, DIDP, DIDP, DIOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9
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    K Number
    K092494
    Device Name
    GEL FILLED GUM SOOTHER
    Manufacturer
    LUV N' CARE, LTD.
    Date Cleared
    2010-03-01

    (199 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.
    Device Description
    Teething Ring – Water or Gel Filled
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    K Number
    K093370
    Device Name
    FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
    Manufacturer
    FU HONG INDUSTRIES LTD.
    Date Cleared
    2010-01-21

    (84 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
    Device Description
    Not Found
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    K Number
    K092910
    Device Name
    FLUID-FILLED TEETHER
    Manufacturer
    QUALIMAN INDUSTRIAL CO., LTD
    Date Cleared
    2009-12-18

    (87 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
    Device Description
    Not Found
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    K Number
    K091198
    Device Name
    LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
    Manufacturer
    ALLIED HILL ENTERPRISES, LTD.
    Date Cleared
    2009-12-07

    (227 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.
    Device Description
    Water Filled Teether
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    K Number
    K083512
    Device Name
    FLUID-FILLED TEETHER
    Manufacturer
    WILTEC INDUSTRIES LTD.
    Date Cleared
    2009-04-22

    (147 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
    Device Description
    Not Found
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    K Number
    K072082
    Device Name
    GUMEASE DENTAL MOUTHPIECE
    Manufacturer
    BIOMEDEVICE LTD.
    Date Cleared
    2007-11-05

    (98 days)

    Product Code
    KKO
    Regulation Number
    872.5550
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.
    Device Description
    The gumEase® dental mouth piece is manufactured from biocompatible plastic tubing that is filled with a NaCl solution.
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