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510(k) Data Aggregation

    K Number
    K250826
    Device Name
    Multi M Series
    Manufacturer
    DMAX Co., Ltd.
    Date Cleared
    2025-06-12

    (86 days)

    Product Code
    EIH, DAT
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi M Series is used in the manufacture of dental prosthesis.
    Device Description
    Multi M Series is zirconia-based ceramic provided in various shapes such as round and it is used to manufacture cores of all ceramic crowns and is classified into ISO 6872 Type 2 Class 5. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 278 different shades to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine. Multi M Series offers various types as follows: W-type, Z-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. Users can choose a type which fits the jig they have.
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    K Number
    K251084
    Device Name
    zirkon; structure; LFU shades, stains and glazes
    Manufacturer
    estetic ceram ag
    Date Cleared
    2025-06-05

    (57 days)

    Product Code
    EIH
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Types of restorations: 1. Anterior and posterior crowns 2. Veneers, inlays, onlays.
    Device Description
    zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.
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    K Number
    K250673
    Device Name
    CERABIEN MiLai
    Manufacturer
    Kuraray Noritake Dental Inc.
    Date Cleared
    2025-05-29

    (84 days)

    Product Code
    EIH, DAT
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in prosthetic dentistry to create an all-ceramic prosthesis. - Ceramic for coverage of a zirconia substructure - Ceramic for coverage of a lithium disilicate substructure [CTE: 9.5~11.0×10-6/K (50-500°C)]
    Device Description
    CERABIEN MiLai is a specific type of porcelain for dental restorations. The system consists of Powder, Paste and Liquids for powder/paste, to be applied utilizing layering technique and baked onto a ceramic frame of zirconia (ZrO2) or different lithium disilicate glasses.
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    K Number
    K250534
    Device Name
    Biomic Color Opaque
    Manufacturer
    Aidite (Qinhuangdao) Technology Co., Ltd.
    Date Cleared
    2025-05-20

    (85 days)

    Product Code
    EIH
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biomic Color Opaque is liquid used for coloring pre-sintered zirconia restorations. It is used for the internal surface of dental zirconia material prosthesis.
    Device Description
    Biomic Color Opaque is a liquid primarily composed of Methylacryloyl propyl trimethoxy silane, deionized water, 1, 3-butanediol, ferric chloride, citric acid, cerium nitrate, erbium nitrate, cobaltous nitrate, manganous acetate, and aluminum nitrate. This product is designed for use on the internal surface of dental zirconia material prostheses. It penetrates tightly with the zirconia surface, forming an extremely thin shade layer that reduces the internal surface permeability of the zirconia material prosthesis. The devices are intended to be used solely by dental technicians for the fabrication of zirconia restorations for individual dental patients. For staining, the zirconia materials must be immersed into the staining solution or brushed with the liquid before sintering at high temperature. The staining solution consists of two components: Type I - a color component (A、B、C、D、W、L、M、R、S、X), and Type II - an OP component, 1:1 collocation is recommended. These components are mixed together for use on the zirconia material to achieve the desired shade.
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    K Number
    K250393
    Device Name
    ZircaGlow & ZircaGlow HT Zirconia
    Manufacturer
    United Zirconia
    Date Cleared
    2025-05-12

    (89 days)

    Product Code
    EIH
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZircaGlow & ZircaGlow HT Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
    Device Description
    ZircaGlow & ZircaGlow HT Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown, bridge or coping.
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    K Number
    K250295
    Device Name
    Dentsply Sirona Titanium Bases system
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2025-04-30

    (89 days)

    Product Code
    NHA
    Regulation Number
    872.3630
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system comprises three parts: - Abutment Block material (CEREC Cercon 4D Abutment Block) - Titanium Base (TiBase) - CAD/CAM system The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.
    Device Description
    The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw. The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018. The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment. The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure. The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure. The minimum/maximum design specification limits are as follows: - Maximum angulation for the Zirconia top-half material: 20˚ - Minimum wall thickness of the Zirconia top-half material: 0.5 mm - Gingival heights of the TiBase component: 1, 2, 3 mm - TiBase component post height (i.e., length above the gingival height): ≥ 4 mm
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    K Number
    K250811
    Device Name
    Dental Zirconia Ceramic
    Manufacturer
    Aidite (Qinhuangdao) Technology Co., Ltd.
    Date Cleared
    2025-04-11

    (25 days)

    Product Code
    EIH
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
    Device Description
    Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Co3O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. Dental Zirconia Ceramic has 19 models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems. The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.
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    K Number
    K250025
    Device Name
    Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
    Manufacturer
    Aidite (Qinhuangdao) Technology Co., Ltd.
    Date Cleared
    2025-03-14

    (67 days)

    Product Code
    EIH
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Porcelain Powder can be used to make facings and veneers of customized denture crowns. It is suitable for adults over 18 years old.
    Device Description
    This product includes Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid. Enamel/ Modifier is Enamel porcelain, its function is to make adjusted porcelain powder gently stacked in the incisal aimed at shape, and stack from incisal to the body, covering dentin porcelain: Stain/Glaze and Stain/Glaze-A is Enamel layer, its function is to coat with a thin layer of glaze on the surface of the finishing porcelain crown to achieve the required color and gloss of natural teeth. Modeling Fluid: A dental ceramic powder is mixed in order to shape or model it into its required form prior to firing
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    K Number
    K250223
    Device Name
    BruxZir® Esthetic NOW
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2025-02-25

    (29 days)

    Product Code
    EIH
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
    Device Description
    BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
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    K Number
    K243940
    Device Name
    VITA YZ Multi Translucent
    Manufacturer
    Vita Zahnfabrik H.Rauter GmbH & Co.
    Date Cleared
    2025-02-21

    (63 days)

    Product Code
    EIH
    Regulation Number
    872.6660
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITA YZ MULTI TRANSLUCENT is indicated for: - · fully anatomical anterior and posterior crowns - · fully anatomical 4 unit anterior and posterior bridges - · fully and partially veneered single tooth and up to 4-unit bridge substructures in the anterior and posterior tooth regions - · inlays - · Onlays - · veneers
    Device Description
    VITA YZ MULTI TRANSLUCENT are zirconia blanks for reliable shade reproduction. They can be used for the production of fully and partially veneered reconstructions and monolithic bridge restorations in the anterior and posterior tooth regions. VITA YZ MULTI TRANSLUCENT is part of the VITA YZ SOLUTIONS product group.
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