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510(k) Data Aggregation

    K Number
    K210349
    Device Name
    TKO Composite Bite Turbo Gel
    Manufacturer
    Reliance Orthodontic Products, Inc
    Date Cleared
    2021-07-20

    (162 days)

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

    Reliance Orthodontic Products, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TKO is a pink, flowable light cure composite gel for the creation of occlusal buildups (bite turbos) and as a retainer repar composite.
    Device Description
    Intended for use in the creation of occlusal buildups (bite turbos) and as a retainer repair composite. It bonds to enamel, porcelain, acrylic and metal for duration of treatment externally communicating device that contacts tissue/bone/dentin. TKO Composite Bite Turbo Gel is dispensed from a precision 3.5 gm LuerLoc syringe with tips.
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    K Number
    K210945
    Device Name
    Ultra SEP
    Manufacturer
    Reliance Orthodontic Products, Inc
    Date Cleared
    2021-07-08

    (100 days)

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

    Reliance Orthodontic Products, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultra SEP is a self etching primer intended to be used for the preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive.
    Device Description
    Ultra SEP is a self etching primer which can etch up to 6 teeth with a single drop. The material is dispensed from a bottle into a light impervious mixing well, and transferred to teeth by a saturated microbrush. Ultra SEP creates an ideal surface for a light cure paste to adhere teeth and brackets for orthodontic treatment. Ultra SEP is used in combination with a light impervious mixing well (SEPW) and microbrushes (MB).
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    K Number
    K130237
    Device Name
    PONTIC PAINT
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2013-04-05

    (64 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners.
    Device Description
    The Pontic Paint is a light cure coloring agent for thermoplastic aligners. The Pontic Paint is formulated in a viscosity that is easily mixed and bonds chemically to a typically difficult to adhere to surface, a thermoplastic aligner now common in the dental industry. This paint, upon polymerization, is in Vita Shades A1. A2, and Bl allowing the appearance of a realistic tooth under the thermoplastic aligner thereby making a missing tooth situation appear aesthetically pleasing to the patient undergoing orthodontic treatment using clear aligner systems. The light cure property of the paint allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set. The Pontic Paint will be marketed in a jar for ease of mixing and application with a brush.
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    K Number
    K123348
    Device Name
    CLEAR ALIGNER ADHESIVE
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2013-02-28

    (120 days)

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

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.
    Device Description
    The Clear Aligner Adhesive is a light cure, orthodontic adhesive for metal, composite and porcelain brackets and appliances to bond to a thermoplastic aligner. The Clear Aligner Adhesive is formulated in a viscosity that flows easily from the syringe and bonds chemically to a typically difficult to adhere to surface. a thermoplastic aligner now common in the dental industry. This adhesive, upon polymerization, is clear and virtually indistinguishable from the thermoplastic aligner thereby making it aesthetically pleasing to the patient. The light cure property of the adhesive allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set. The Clear Aligner Adhesive will be marketed in a push syringe for dispensing.
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    K Number
    K111814
    Device Name
    PADLOCK
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2011-09-14

    (79 days)

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

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light Bond is intended for use as an orthodontic bracket adhesive. Pad Lock® is intended for use as a fluorescing, light cure Orthodontic Bracket Adhesive.
    Device Description
    Light Bond and Pad Lock are light cure, orthodontic bracket adhesives available in a variety of viscosities for bonding to metal, ceramic and composite surfaces. Both Light Bond and Pad Lock are available in fluoride and non-fluoride formulas and come in syringe style or tip dispensing. In addition, Pad Lock fluoresces to ease clean-up of flash for the user.
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    K Number
    K101951
    Device Name
    LIGHT CURE RETAINER
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2010-10-26

    (106 days)

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

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    L.C.R." is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for the retention of thermo-plastic aligners.
    Device Description
    L.C.R."" is a light-cure orthodontic adhesive that is flowable and a highly filled resin in order to provide durability. These properties make it ideal for bonding lingual retainers, creating occlusal buildups and for the retention of a thermoplastic aligner. L.C.R is available in push syringe, luer-lok syringe or tips for preferences in dispensing.
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    K Number
    K083051
    Device Name
    FLOWTAIN & FLOWTAIN LV
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2009-02-20

    (129 days)

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

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flowtain™ is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers and splinting materials, creation of archwire stops and indirect bonding of orthodontic brackets. Flowtain™ can also be used for the retention of thermoplastic aligners. Flowtain™ LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.
    Device Description
    Flowtain™ is a light-cure orthodontic adhesive with a low modulus of elasticity that is flowable. This low modulus of elasticity makes it ideal for bonding lingual retainers, splinting materials and for indirect bonding of brackets. Thixotropic design properties of Flowtain™ also make it highly polishable which allows it to be used for comfortable archwire stops and as an aid for retention of a thermoplastic aligner. Flowtain™ LV is a low viscosity version of the Flowtain™ product used primarily for indirect bonding of brackets. Both are available in push syringe or tips for preferences in dispensing.
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    K Number
    K073243
    Device Name
    LED PRO SEAL
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2008-02-08

    (81 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LED PRO SEAL® is intended to seal enamel surfaces around orthodontic brackets.
    Device Description
    LED PRO SEAL® is a fluoride containing light cure filled surface sealant provided in a light impervious bottle dispenser. Upon delivery of one drop of LED PRO SEAL to a mixing pad, a thin coat of LED PRO SEAL is applied to a prepared enamel surface using a brush applicator and light cured for a minimum of 20 seconds with any halogen, plasma arc or cordless light capable of a 440-490 NM wavelength.
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    K Number
    K071688
    Device Name
    RELIANCE S.E.P.
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2007-09-07

    (79 days)

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

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive.
    Device Description
    The Reliance S.E.P. is a one step self etching primer contained in a handheld dispenser. Upon manual compression into a light impervious mixing well, enough solution is dispensed to prepare the enamel surface of up to 20 teeth.
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    K Number
    K071590
    Device Name
    THERMA-CURE
    Manufacturer
    RELIANCE ORTHODONTIC PRODUCTS, INC.
    Date Cleared
    2007-07-31

    (50 days)

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

    RELIANCE ORTHODONTIC PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Therma-Cure is a heat cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the indirect bonding of orthodontic brackets and appliances.
    Device Description
    Therma-Cure™ is a heat curable orthodontic adhesive used for the indirect bonding of orthodontic brackets and appliances.
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