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510(k) Data Aggregation

    K Number
    K251252
    Device Name
    NOBILCAM IMPAK Disc
    Manufacturer
    Shandong Huge Dental Material Corporation
    Date Cleared
    2025-08-01

    (100 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Huge Dental Material Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K220680
    Device Name
    Denture Base Polymers
    Manufacturer
    Shandong Huge Dental Material Corporation
    Date Cleared
    2022-08-12

    (157 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Huge Dental Material Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.
    Device Description
    Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.
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    K Number
    K213994
    Device Name
    Flexible Block
    Manufacturer
    Shandong Huge Dental Material Corporation
    Date Cleared
    2022-03-04

    (73 days)

    Product Code
    EBI, MQC
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Huge Dental Material Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for making dental plates, bite plates, frame-works, clasps,personal trays, appliances, occlusal splints and night guards.
    Device Description
    Flexible Block is a circular solid (disc) or rectangular solid (block) made from polyamide through high-temperature injection molding, and is used in a CAD/CAM milling machine for production of dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal night guards. These blocks are available in a variety of shapes and sizes for different milling systems and in a variety of dental shades.
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    K Number
    K201684
    Device Name
    A-Silicone for Bite Registration
    Manufacturer
    Shandong Huge Dental Material Corporation
    Date Cleared
    2020-09-24

    (94 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Huge Dental Material Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A-Silicone for Bite Registration is indicated for making occlusal registrations.
    Device Description
    A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.
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    K Number
    K181747
    Device Name
    Orthodontic Appliance
    Manufacturer
    Shandong Huge Dental Material Corporation
    Date Cleared
    2019-04-18

    (290 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Huge Dental Material Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.
    Device Description
    The Orthodontic Appliance is a series of clear, lightweight, plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The product is made of a polymer thermoplastic material (polyvinyl ester mixture) by pressing. The doctor-prescribed Orthodontic Appliance are provided non-sterile and are customized for each patient according to the 3D printed data designed by Clear Aligner Design Software. Shandong Huge Dental Material Corporation manufactures the Orthodontic Appliance by thermoforming commercially available thermoplastic material and send them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each pair of appliance is 2-3 weeks, wear the appliances for at least 20 hours every day and it is to be worn except during eating or cleaning of the oral cavity. The type of Orthodontic Appliance is LX-A with various thickness so that the clinician can select suitable thickness based on patients' teeth micromaxillary deformity conditions. Different thickness are identical in chemical compositions, indications for use, functions, performance characteristics, operation principle and other aspects.
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    K Number
    K160345
    Device Name
    Glass Ionomer Cement
    Manufacturer
    SHANDONG HUGE DENTAL MATERIAL CORPORATION
    Date Cleared
    2017-03-03

    (389 days)

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

    SHANDONG HUGE DENTAL MATERIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications: (1) Restoration of primary teeth. (2) Restorations of Class III, V and limited Class I cavities. (3) Base linings under composite and amalgam. (4) Core build-up.
    Device Description
    Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.
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    K Number
    K161851
    Device Name
    Glass Ionomer Cement (Luting)
    Manufacturer
    SHANDONG HUGE DENTAL MATERIAL CORPORATION
    Date Cleared
    2016-10-31

    (117 days)

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

    SHANDONG HUGE DENTAL MATERIAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Self-curing glass ionomer based radiopaque luting cement, for dental use only. Recommended indications: (1) Cementation of metal-based inlays, onlays, crowns and bridges; - (2) Cementation of high strength (zirconia based) all ceramic crowns and bridges; - (3) Cementation of posts and screws made of metal or high-strength ceramic; - (4) Cementation of orthodontic bands; - (5) Restoration of caries in unstressed area (Luting II only).
    Device Description
    Glass Ionomer Cement (Luting) has two models: Luting II. It is a device composed of various materials mainly including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as luting to affix dental devices such as metal-based inlays, onlays, crowns, bridges, and orthodontic bands. It's a powder liquid system, with each part is packaged separately when not in use. The basic operation principle of Glass Ionomer Cement (Luting) is acid-base reaction.
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