Devices & Diagnostics > Device

Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.


by SUN MEDICAL CO.,LTD.
Product Overview

Coating Material is a light
Coating Material - MC-002


Device Description

A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 10.00
    • 1.00


    • Device Sizes

  • Weight: 1.43 Kilogram
    • Weight: 1.43 Kilogram


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: EBI

    Device Name: Resin, Denture, Relining, Repairing, Rebasing

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: DE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 872.3760

    Third Party Flag: Y

    Medical Specialty: DE


    Device Identifiers

    Device Id: 04560227798990

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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