Silk Line Refill Cartridge

GUDID 18522530060143

Refill Cartridge for Silk Line Denture Reliner

J. MORITA U.S.A., INC

Denture reliner, soft, professional Denture reliner, soft, professional

• Primary Device ID: 18522530060143
• NIH Device Record Key: c17389f0-934e-4565-ae86-e9b5ef2baddc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silk Line Refill Cartridge
• Version Model Number: 28100200
• 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: false
• 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	18522530060143 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Silk Line Refill Cartridge]

• 18522530060143: Refill Cartridge for Silk Line Denture Reliner
• 10852253006141: Refill Cartridge for Silk Line Denture Reliner