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510(k) Data Aggregation

    K Number
    K242014
    Device Name
    Jet Flow Bulk
    Manufacturer
    META Biomed Co., Ltd.
    Date Cleared
    2024-10-08

    (90 days)

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

    META Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Base under Class I and II direct restorations - Pit and fissure sealant - Class III and V restorations - Repair of resin, porcelain and acrylic temporary materials - Liner under direct restorative materials
    Device Description
    Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent enabling up to a depth of 3~5mm at a time. Jet Flow Bulk is packaged in disposable tips and two syringes that include restorative materials. The shades offered with Jet Flow Bulk are Universal(U), Dentin(D), A1, A2, A3. Jet Flow Bulk contains bisGMA, UDMA, bisEMA. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.053 to 6.76 microns and silica with a particle size range of 0.04 to 0.452 um. The inorganic filler loading is approximately 35.6 vol.% (61.0wt.%).
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    K Number
    K232299
    Device Name
    CeraPutty
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2023-09-29

    (59 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meta Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Repair of Root Perforation - Repair of Root Resorption - Root End Filling - Apexification - Pulp Capping
    Device Description
    CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications. It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent. CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties. CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment. Ceraputty is packaged in a preloaded syringe.
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    K Number
    K230010
    Device Name
    ADSEAL Plus
    Manufacturer
    Meta Biomed Co., LTD.
    Date Cleared
    2023-04-13

    (100 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meta Biomed Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ADSEAL Plus is a biocompatible root canal sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). ADSEAL Plus is intended for use by qualified healthcare personnel trained in its use.
    Device Description
    ADSEAL Plus root canal sealer is a two component paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of two components, the epoxy resin paste (Paste A) and the amine-containing paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator. The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
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    K Number
    K230009
    Device Name
    EZ Bond Universal
    Manufacturer
    Meta Biomed Co., LTD.
    Date Cleared
    2023-03-03

    (59 days)

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

    Meta Biomed Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - All classes of fillings (according to Black) with light-curing composite or compomer filling materials - Repair of composite resin or compomer fillings - Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer - Protective varnish for glass ionomer fillings
    Device Description
    EZ Bond Universal, manufactured by Meta Biomed, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200). EZ Bond universal is a single-bottle solution. Depending on the indication, the adhesive can be used for direct and indirect restorations with light cured composites in a "self-etching" procedure, "total-etching" procedure or" selective-etching" procedure. EZ Bond Universal is methacrylate-based restoratives, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (glass ceramics, alumina and zirconia) without an extra primer step.
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    K Number
    K210904
    Device Name
    Metapaste Plus
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2021-06-30

    (96 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meta Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth. Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.
    Device Description
    Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.
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    K Number
    K202617
    Device Name
    Metapex Plus
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2021-04-14

    (217 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meta Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Metapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material/Apexification and hard tissue formation/Apexogensis
    Device Description
    This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of iodoform contained. Metapex Plus is used for patients of all ages requiring root canal treatment.
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    K Number
    K191991
    Device Name
    Ezfil
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2020-03-05

    (224 days)

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

    Meta Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Direct anterior and posterior restorations (including occlusal surfaces) - Core Build-ups - Splinting - Indirect restorations including inlays, onlays and veneers
    Device Description
    Dental composite resin is a device intended to restore carious lesions or structural defects in teeth. Ezfil is indicated for Class I , II, IV, V restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs. The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.
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    K Number
    K190503
    Device Name
    CeraSeal
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2019-06-07

    (98 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meta Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · Permanent obturation of the root canal following vital pulp-extirpation · Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings CeraSeal is suitable for use in the single cone and lateral condensation technique.
    Device Description
    CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
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    K Number
    K190510
    Device Name
    GuttaSil
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2019-05-29

    (89 days)

    Product Code
    KIF, EKM
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meta Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.
    Device Description
    GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
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    K Number
    K181689
    Device Name
    Nexcomp
    Manufacturer
    Meta Biomed Co., Ltd.
    Date Cleared
    2018-11-15

    (142 days)

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

    Meta Biomed Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class I, III, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.
    Device Description
    Nexcomp is a light-cured, esthetic, resin-based dental restorative designed for direct placement in both anterior and posterior restorations. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra-fine filler and 40 nm silica particles. Nexcomp will be marketed in 19 shades which corresponded with the Vita Shade Guide.
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