Silk Line Kit

GUDID 10852253006134

Soft Denture Relining Material

J. MORITA U.S.A., INC

Denture reliner, soft, professional

• Primary Device ID: 10852253006134
• NIH Device Record Key: c68165b5-578f-4809-980e-12d949433e7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silk Line Kit
• Version Model Number: 28100100
• Company DUNS: 021866033
• Company Name: J. MORITA U.S.A., INC
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10852253006134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060844

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: 4
• Public Version Date: 2020-01-28
• Device Publish Date: 2016-09-22

On-Brand Devices [Silk Line Kit]

• 18522530060136: Soft Denture Relining Material
• 10852253006134: Soft Denture Relining Material