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510(k) Data Aggregation

    K Number
    K250015
    Device Name
    Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
    Manufacturer
    Ormco Corporation
    Date Cleared
    2025-01-03

    (1 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement without etching. Ormco™ EtchFree Adhesive is a light-curing adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.
    Device Description
    The Ormco™ Bonding System consists of a primer, a sealant, an adhesive, and bonding accessories. · Ormco™ Bonding Primer is intended to bond orthodontic appliances such as metal brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement. The primer is a clear liquid that conditions the surface of the application of a bonding sealant/enhancer. Ormco Bonding Primer is designed to be used as a system along with Ortho Solo and Ormco" Bonding Adhesive. The primer is offered in single-use vials which will be sold in kits and separately. · Ormco™ Adhesive is a light-curing composite that is intended to be used with metal and ceramic brackets for orthodontic treatment and can also be used as aligner attachment. It is a convenient off-white paste providing aesthetics when used as aligner attachments or beneath a bracket. The adhesive is designed to be used as a system along with Ormco Bonding Primer and Ortho Solo. The adhesive is offered in syringes for multi-patient use, which will be sold in kits and separately.
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    K Number
    K242537
    Device Name
    BracePaste Fluoride Sealant
    Manufacturer
    American Orthodontics Corp.
    Date Cleared
    2024-08-27

    (1 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel. BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.
    Device Description
    American Orthodontics' BracePaste Fluoride Sealant is a light-curing primer that is intended for use in orthodontic treatment as diagnosed by a trained dental professional or orthodontist. The primer prepares the enamel during orthodontic treatment to increase adhesion to the bonding surface by wetting the bonding surface of the object to be bonded.
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    K Number
    K234043
    Device Name
    3M™ Transbond™ Orthodontic Adhesive
    Manufacturer
    3M Unitek Orthodontic Products
    Date Cleared
    2023-12-22

    (1 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M Transbond Orthodontic Adhesive is indicated for the following uses: - · Creating attachments for orthodontic tray aliqners. - · Bonding orthodontic brackets to teeth.
    Device Description
    3M Transbond Orthodontic Adhesive is a thixotropic, visible-light activated, radiopaque orthodontic adhesive. The product is stored in a multi-use syringe which is used with single-use dispensing tips. 3M Transbond Orthodontic Adhesive contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
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    K Number
    K231817
    Device Name
    AlignerFlow LC
    Manufacturer
    VOCO GmbH
    Date Cleared
    2023-12-01

    (163 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Retention of aligners e.g. by fabrication of aligner attachments - Bonding of lingual retainers - Occlusal build-ups
    Device Description
    Not Found
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    K Number
    K214054
    Device Name
    TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
    Manufacturer
    TP Orthodontics, Inc.
    Date Cleared
    2022-10-14

    (291 days)

    Product Code
    DYH, KLE
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface. TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment. TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
    Device Description
    TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive are light cure orthodontic adhesive used for bonding the orthodontic brackets, molar tubes, and buccal tubes to the surface of teeth for orthodontic treatment. The variations available are: - . TP Orthodontics Light Cure Adhesive System, which consists of an adhesive paste (will be available in a pre-loaded syringe), and sealant. - . TP Orthodontics Pre-Applied Adhesive, consisting of bracket adhesive pre-applied to the bracket pad. The adhesives prevent bracket drift during placement, and is easy to clean-up excess (flash') prior to curing. The adhesive is polymerized ('cured') by exposure to a dental curing light, and once cured it creates a bond, attaching the orthodontic appliance to the teeth. TP Orthodontics Etchant is a phosphoric acid etchant used on tooth enamel or dentin in preparation for orthodontic bonding. It is a blue gel and will be contained in a syringe, which will use disposable dispensing tips for its controlled application.
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    K Number
    K210115
    Device Name
    FiteBac CC OrthoSeal
    Manufacturer
    Largent Health, LLC
    Date Cleared
    2021-07-29

    (191 days)

    Product Code
    DYH, FIT
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
    Device Description
    The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.
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    K Number
    K192682
    Device Name
    Orthocem, Ortho Bite
    Manufacturer
    Dentscare Ltda
    Date Cleared
    2020-08-14

    (323 days)

    Product Code
    DYH, EBF
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthocem: Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface. Ortho bite: The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.
    Device Description
    Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product's removal from teeth, after removing brackets. Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. Its composition includes dimethacrylate monomers, HEMA Phosphate, traditional Camphorquinone/DABE system as photoinitiator and silica as load particle. The combination of silica load fillers with the dimethacrylate monomer composition results in a viscosity that allows it to be handled and applied without running off the application area. The presence of HEMA Phosphate allows adhesion to the enamel surface, which is a known feature of composite cements indicated for bracket bonding. The thixotropy allows the product to have self-levelling capability, known as a shear thinning property that makes the composite settle correctly on the occlusal surface. The product is colored in order to facilitate its identification during application and removal.
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    K Number
    K202276
    Device Name
    BracePaste Band and Build LC
    Manufacturer
    American Orthodontics
    Date Cleared
    2020-08-14

    (3 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A light cure orthodontic band cement intended to bond orthodontic bands to teeth.
    Device Description
    American Orthodontics' BracePaste Band and Build LC is a light-cure band cement that is intended to bond orthodontic bands to teeth. When an orthodontic band is required for orthodontic treatment, band cement is applied to the inside of the orthodontic band and then the band is seated onto the tooth. Once the band is seated properly, excess adhesive is cleaned up from the proximity of the band and tooth and the adhesive is cured via curing light. The polymerization of the adhesive forms a bond between the orthodontic band and / or the tooth enamel. Upon completion of orthodontic treatment, the orthodontic band is removed and any adhesive remaining on tooth enamel is cleaned up and removed from the tooth.
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    K Number
    K193388
    Device Name
    GlassLok Kits, GlassLok Powder, GlassLok Liquid
    Manufacturer
    Reliance Orthodontic Products Inc.
    Date Cleared
    2020-04-27

    (143 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.
    Device Description
    GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. GlassLok can be used to bond molar bands to an enamel or metal substrate in a wet or dry field due to its hydrophilic properties. GlassLok is available in natural or blue shade (for easy disclosure at removal). GlassLok is dispensed in a 2 part (powder and liquid) format with bottle dispensing. A 15cc and 25 cc liquid (in blue or natural shade) along with a 15gm or 100gm powder component will be available as separate components. A convenience kit will also be available in Blue or Natural shade in a starter or economy volume. GlassLok powder is dispensed to a mixing pad using a measuring scoop and mixed with GlassLok liquid in a ratio of 2:1. The mixed GlassLok composite is then applied to the inside of an orthodontic band and applied to a properly prepared tooth structure. Working Time is 2 minutes and setting time is 5 minutes once the working time has expired. GlassLok can also be cured with a curing light for 20 seconds, if required for polymerization. Associated accessories include a measuring scoop. Spatula and mixing pad.
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    K Number
    K183147
    Device Name
    BrackFix
    Manufacturer
    VOCO GmbH
    Date Cleared
    2019-03-01

    (108 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Product Code :

    DYH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct bonding of orthodontic metal and ceramic brackets
    Device Description
    Not Found
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