Final Varnish LC 1241

GUDID E22112411

Light-curing varnish for glass ionomer materials

VOCO GmbH

Dental restorative material varnish

• Primary Device ID: E22112411
• NIH Device Record Key: 4073fa38-3d34-44df-a5d9-6786ff6c6e4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Final Varnish LC
• Version Model Number: 1241
• Catalog Number: 1241
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22112411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030844

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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