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510(k) Data Aggregation

    K Number
    K222581
    Device Name
    Stela Automix System
    Manufacturer
    SDI Limited
    Date Cleared
    2022-10-28

    (63 days)

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

    SDI Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stela Primer: - Dentin and enamel bonding Stela Automix: - Direct Class I, II, III and V cavities. Ideally Class I and II. - Base or liner - Core build-ups.
    Device Description
    The Stela Automix System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises: - Stela Automix a double-barrel syringe containing two pastes which are mixed and dispensed with a single-use mixing tip and - Stela Primer - an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer. The combination of Stela Primer and Stela Automix will bond to both enamel and dentin without scrubbing or light curing.
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    K Number
    K222583
    Device Name
    Stela Capsule System
    Manufacturer
    SDI Limited
    Date Cleared
    2022-10-28

    (63 days)

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

    SDI Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stela Primer: - Dentin and enamel bonding Stela Capsule - Direct Class I, II, III and V cavities. Ideally Class I and II - Base or liner - Core build-ups.
    Device Description
    The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises: - Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste. - Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer. The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
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    K Number
    K214118
    Device Name
    Riva Cem Automix
    Manufacturer
    SDI Limited
    Date Cleared
    2022-08-30

    (243 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SDI Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent cementation of: - 1) Porcelain fused to metal (PFM) to crowns and bridges - 2) Prefabricated/cast posts - 3) Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts - 4) Ceramics (high strength)* to crowns & bridges, inlays & onlays - *E.g. Zirconia, Lithium Disilicate, - 5) Ceramics (low strength)* to inlays - *E.g. Feldspathic porcelains, Glass ceramics
    Device Description
    Riva Cem Automix™ is a radiopaque, fluoride releasing, resin modified glass ionomer luting cement. Riva Cem Automix™ is intended for the cementation of crowns, bridges, inlays, posts (fibre-reinforced), and orthodontic appliances. Riva Cem Automix™ consists of a base paste and a catalyst paste packaged in the automix delivery system for direct delivery in consistent mix ratios. Riva Cem Automix™ is available in a universal light-yellow shade in a double barrel syringe. The automix tip offers convenience over traditional hand mixed systems. The product provides both self-cure and tack cure mechanisms which makes it versatile for the cementation of different restorative systems.
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    K Number
    K191656
    Device Name
    Zipbond
    Manufacturer
    SDI Limited
    Date Cleared
    2019-12-02

    (164 days)

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

    SDI Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct Applications: - Light cured composite restorations - Light cured compomers - Cavity sealing prior to placement of indirect restorations - Composite repair of porcelain and hybrid ceramic restorations - Sealing exposed root surfaces which are causing hypersensitivity - Core build ups using light cure/dual cure composites - Protective varnish for glass ionomer (GI) filling Indirect Applications: - Cementation indirect restorations
    Device Description
    Zipbond is a single-component, (meth)acrylate-based material which functions as a combined etch-and-rinse (total-etch), self-etch and selective-etch dental adhesive. It offers an adhesive application technique for both direct indications and bonds to enamel, dentin, composites, cements. When used with a LED light curing device, Zipbond can be used with self-cure, dual-cure and light cure resin cements, composites and core-build up materials. Zipbond provides the operator with three choices of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching required prior to application, Selective-etch mode: selective phosphoric acid etching to enamel, Total-etch mode: phosphoric acid etching of both enamel and dentin.
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    K Number
    K172047
    Device Name
    Riva Star
    Manufacturer
    SDI Limited
    Date Cleared
    2018-04-11

    (279 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    SDI Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
    Device Description
    Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.
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    K Number
    K102984
    Device Name
    AURA
    Manufacturer
    SDI LIMITED
    Date Cleared
    2010-12-08

    (62 days)

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

    SDI LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct anterior/posterior restorations and veneers. Core build ups. Indirect inlays, onlays and veneers. Splinting. Composite and porcelain repair. Sandwich technique with glass ionomers. For professional use only.
    Device Description
    Not Found
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