Coating Material KS51US

GUDID 04560227798990

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

SUN MEDICAL CO.,LTD.

Denture reliner, hard

• Primary Device ID: 04560227798990
• NIH Device Record Key: 43d5fa2e-f263-45f9-82f3-daa4698f823e
• Commercial Distribution Discontinuation: 2017-07-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Coating Material
• Version Model Number: MC-002
• Catalog Number: KS51US
• Company DUNS: 690922612
• Company Name: SUN MEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 1.43 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560227798990 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-11-09

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