ProLink 15SEUN

GUDID 07290015358859

Dental Adhesive

SILMET LTD

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• Primary Device ID: 07290015358859
• NIH Device Record Key: d184b613-3f5d-46b1-9547-4a5a823fab5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLink
• Version Model Number: 15SEUN
• Catalog Number: 15SEUN
• Company DUNS: 600071344
• Company Name: SILMET 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015358859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110403

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2018-12-28
• Device Publish Date: 2016-11-28

On-Brand Devices [ProLink]

• 07290016787627: Dental Adhesive
• 07290015358859: Dental Adhesive
• 07290015358835: Dental Adhesives