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510(k) Data Aggregation

    K Number
    K232498
    Device Name
    UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
    Manufacturer
    Ultradent Product, Inc.
    Date Cleared
    2023-08-18

    (1 days)

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

    Ultradent Product, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraSeal XT plus bioprotection by Nobio sealant - UltraSeal XT plus sealant for prophylactic sealing of pits and fissures and can be used where the use of a flowable composite is indicated. The bioprotection by Nobio reduces demineralization, which is part of the caries formation process. UltraSeal XT hydro bioprotection by Nobio sealant - Use UltraSeal XT hydro sealant for prophylactic sealing of pits and fissures. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
    Device Description
    UltraSeal XT plus bioprotection by Nobio sealant and flowable composite – UltraSeal XT plus sealant is a 58% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is used with PrimaDry drying and priming agent to aid in avoiding moisture contamination which can cause microleakage and poor retention. It is a Type 1 Class 2 Group 1 polymer-based dental restorative flowable resin which is suitable for occlusal surfaces. It can be used where the use of a flowable is indicated. It is compatible with adhesives and bonding agents. UltraSeal XT plus sealant has a radiopacity value of 1.44 mm of aluminum. Aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material (having a radiopacity equivalent to 1 mm of aluminum) has a radiopacity equivalent to that of dentin-and 2 mm of aluminum is equivalent to enamel. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process. UltraSeal XT hydro bioprotection by Nobio sealant – UltraSeal XT hydro sealant is a Class 2, 53% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is partly hydrophobic and hydrophilic before it is cured, hydrophobic once cured, and has a selfadhesive quality. UltraSeal XT hydro sealant chemistry provides the option of a visual verification for marginal retention-with the use of a black light upon placement and at recall visits. The UV light is not included in the UltraSeal XT hydro sealant kit. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process. Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the sealant and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis. Both subject devices have a depth of cure ≥ 1.5mm, are curable at wavelengths of 385-515nm and will remain uncured after light exposure while in their primary container. UltraSeal XT plus Bioprotection by Nobio is also indicated for use as a flowable composite. It has a flexural strength of ≥ 80 MPa, Water Sortpion ≤ 40 µ g/mm3, Water Solubility ≤ 7.5 µ g/mm3, Radio-Opacity, ≥ 1mm of Al, Surface Hardness ≥ 20 HK and Ambient light sensistivity resulting in the product being physically homogeneous after 60 seconds.
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    K Number
    K201795
    Device Name
    Transcend
    Manufacturer
    Ultradent Product, Inc.
    Date Cleared
    2020-09-28

    (90 days)

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

    Ultradent Product, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcend universal composite is used for direct restorations in both the anterior and posterior regions.
    Device Description
    Transcend is a light cured, tooth shade resin composite material (Bis-GMA based) to be used for posterior and anterior tooth restorations. Transcend is radiopaque and available in a range of dentin, enamel, and body shades. It is 81% filled by weight and 58% filled by volume and has an average particle size of 0.9μm (by weight) with narrow upper limit particle distribution. Composite Wetting Resin is a 45% filled, radiopaque light cured wetting resin. Composite Wetting Resin helps to improve the glide of the instrument during and contouring. It may be used during the placement of composite if the composite has become dry during incremental layering, or if the oxygen inhibition layer has been removed or disturbed. The wetting agent is an accessory and, if necessary, is used in conjunction with Transcend.
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