DEVICE: Coating Material (04560227798990)

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Device Identifier (DI) Information

Coating Material
MC-002
KS51US
SUN MEDICAL CO.,LTD.
04560227798990
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Denture reliner, hard A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a hard condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 1 and 10 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 1.43 Kilogram
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Device Status

Not in Commercial Distribution
November 09, 2016
July 27, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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