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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?
    Product Code :

    EBC

    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
    K230455
    Device Name
    Enamel Coating Resin
    Manufacturer
    Rizhao HuGe Biomaterials Company, Ltd.
    Date Cleared
    2023-07-25

    (154 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Proseal Enamel Coating Resin is a light curing material for sealing the enamel pits and fissures of teeth.
    Device Description
    Proseal Enamel Coating Resin is a light-curing fissure sealant and is mainly composed of methacrylate resin, photo initiator system and inorganic fillers. It is packaged in syringes or bottles.
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    K Number
    K190998
    Device Name
    BA Pit & Fissure Sealant
    Manufacturer
    Apex Dental Materials, Inc.
    Date Cleared
    2019-11-08

    (206 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only.
    Device Description
    Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure. BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material.
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    K Number
    K190339
    Device Name
    Helioseal F Plus
    Manufacturer
    Ivoclar Vivadent, AG
    Date Cleared
    2019-07-29

    (165 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Helioseal F Plus is used to seal fissures, pits and foramina caeca.
    Device Description
    Helioseal® F Plus is a light-curing, white shaded fissure sealant featuring fluoride release. Helioseal F Plus is supplied in either a syringe or cavifil delivery form. The fissure sealant is composed of dimethacrylates. In the handling technique, the dental professional will clean the enamel surface to be sealed, isolate the working field, conditioning is performed, a thorough rinse and dry to remove the conditioner, before the application of Helioseal F Plus to the tooth surface.
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    K Number
    K172169
    Device Name
    Pulpdent (Activa) Pit and Fissure Sealant with MCP
    Manufacturer
    Pulpdent Corporation
    Date Cleared
    2018-01-05

    (171 days)

    Product Code
    EBC, EBF
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulpdent's Activa Pit and Fissure Sealant with MCP is intended to seal pit and fissure depressions/faults in the enamel, in the biting surfaces of teeth. For dental professional use only.
    Device Description
    Activa Pit and Fissure Sealant is a light cured, flowable dental sealant material, available in a single barrel syringe. This sealant is designed with MCP (Modified Calcium Phosphate); it releases calcium, phosphate, and fluoride ions into the oral environment. It contains no Bisphenol A, no BisGMA, and no BPA derivatives.
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    K Number
    K171330
    Device Name
    Nanova Sealant
    Manufacturer
    Nanova Biomaterials Inc
    Date Cleared
    2017-09-08

    (126 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nanova Sealant is indicated for use as a pit and fissure sealant
    Device Description
    Not Found
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    K Number
    K162598
    Device Name
    HAPI Seal
    Manufacturer
    BISCO, INC.
    Date Cleared
    2017-05-23

    (246 days)

    Product Code
    EBC, CLA
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pit and fissure sealant
    Device Description
    HAPI Seal is a light-cured, fluoride containing, resin-based pit & fissure sealant designed for sealing the enamel pits and fissures of teeth.
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    K Number
    K161580
    Device Name
    Premier Sealant
    Manufacturer
    PREMIER DENTAL COMPANY PRODUCTS
    Date Cleared
    2016-10-18

    (132 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.
    Device Description
    Not Found
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    K Number
    K141717
    Device Name
    PACSEAL PIT & FISSURE SEALANT
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2015-03-09

    (257 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PacSeal™ Pit & Fissure Sealant is intended for use as: - Seal the pits and fissures in teeth
    Device Description
    PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth.
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    K Number
    K130485
    Device Name
    CONTROL SEAL
    Manufacturer
    VOCO GMBH
    Date Cleared
    2014-02-11

    (351 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Product Code :

    EBC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Sealing / filling of pits and fissures - Sealing / facing of damaged enamel surfaces - Covering of predilection sites, e.g., within the scope of orthodontic treatments - Sealing of composite or glass ionomer fillings (profective layer against moisture) - Sealing of deciduous teeth - Extended fissure sealing
    Device Description
    Not Found
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