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510(k) Data Aggregation

    K Number
    K242530
    Device Name
    HF-Etchant Hydrofluoric Acid Etching Gel
    Manufacturer
    Rizhao HuGe Biomaterials Company, Ltd.
    Date Cleared
    2024-12-20

    (116 days)

    Product Code
    KLE, EIH, PME
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
    Device Description
    HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast. HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
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    K Number
    K242749
    Device Name
    TopCEM Ceramic Primer Ceramic Coupling Agent
    Manufacturer
    Rizhao HuGe Biomaterials Company, Ltd.
    Date Cleared
    2024-11-08

    (57 days)

    Product Code
    KLE, EMA
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.
    Device Description
    TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use. TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.
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    K Number
    K242675
    Device Name
    FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
    Manufacturer
    Spident Co., Ltd.
    Date Cleared
    2024-11-01

    (56 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth) · Remove smear layer of dentin and enamel • Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)
    Device Description
    FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.
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    K Number
    K240153
    Device Name
    Ceramic Etchant (HF-5 and HF-9)
    Manufacturer
    Liaoning Upcera Co., Ltd
    Date Cleared
    2024-10-02

    (257 days)

    Product Code
    KLE, EIH, PME
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramic Etchant is intended for etching the porcelain veneers, crowns, and inlays extraorally. It is also used for pretreating the porcelain veneers, crowns, and inlays extraorally before bonding.
    Device Description
    Not Found
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    K Number
    K241445
    Device Name
    K-Bond Universal
    Manufacturer
    Spident Co., Ltd.
    Date Cleared
    2024-07-22

    (61 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    -Bonding of all direct composite restorations -Bonding of dual/self cure composite and core build-ups -Repairs of composite fillings -Root surface desensitization
    Device Description
    K-Bond Universal is a bonding system that offers exceptional bonding strength through a convenient single bottle application. This single-component bonding agent is specifically formulated to effectively bond various types of direct composite restorations to dentin, enamel, as well as composite.
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    K Number
    K241056
    Device Name
    Light Cure Adhesive
    Manufacturer
    Sincera Technology (Changchun) Co., Ltd.
    Date Cleared
    2024-07-16

    (89 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures: - Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives; - Repair of dental restorations of ceramic, composites and/or metal alloys; - Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
    Device Description
    Not Found
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    K Number
    K240743
    Device Name
    Peak Universal Bond
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2024-03-20

    (2 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure. Peak Universal Bond adhesive bonds to the following materials: - · Dentin and Enamel - · Porcelain, Zirconia - Metal - · Composite
    Device Description
    Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.
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    K Number
    K231039
    Device Name
    CLEARFIL Universal Bond Quick 2
    Manufacturer
    Kuraray Noritake Dental Inc.
    Date Cleared
    2023-12-13

    (245 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - [1] Direct restorations using light-cured composite resin - [2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations - [3] Treatment of exposed root surfaces - [4] Treatment of hypersensitive teeth - [5] Intraoral repairs of fractured restorations - [6] Post cementation and core build-ups - [7] Cementation of indirect restorations
    Device Description
    CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.
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    K Number
    K232978
    Device Name
    DX. Bond V Dental Bonding Adhesive
    Manufacturer
    Sino-Dentex Co., Ltd.
    Date Cleared
    2023-09-22

    (366 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1.Bonding for all Classes of direct composite restoration 2.Bonding for indirect procedures involving metal, porcelain, and composite
    Device Description
    DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.
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    K Number
    K231696
    Device Name
    Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2023-08-11

    (60 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Product Code :

    KLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair. Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations. Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.
    Device Description
    Prevest Denpro Tooth Bonding Agents attach different types of restorations to teeth. Fusion Bond 5 is a light curing single component bonding agent. It primes and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Tooth structures should have a 37% phosphoric acid etchant application of Fusion Bond 5. Fusion Bond 7 is a light curing single component bonding agent. It etches, primes, and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Fusion Bond DC is a dual cure bonding direct and indirect restorations. Enamel and dentin surfaces should be conditioned with 37% phosphoric acid etchant before application of Fusion Bond DC. It is a two component adhesive with bonding agent and activator. Renew MDP is a light curing single component bondines etching, priming and bonding in one bottle. It is an ethanol-water based dental adhesive containing 10-Methacryloyloxydececyl Dihydrogen Phosphate (10-MDP) a functional monomer which helps in bonding to dentin and cut and un-cut enamel. Renew MDP works with light-cured and dual-cured composite materials. Renew Universal is a light curing single component bondines etching, priming and bonding. Renew Universal contains a combination of functional monomers such as 10-MDP and 4-META. Renew Universal works with light-cured and dual-cured composite materials.
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