Easy Glaze 1016

GUDID E22110161

Easy Glaze is a nanofilled, light-cured coating with natural fluorescence for sealing surfaces.

VOCO GmbH

Dental restorative material varnish

• Primary Device ID: E22110161
• NIH Device Record Key: 4c8e9401-3a5e-4ec8-9737-968dbe13f272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Glaze
• Version Model Number: 1016
• Catalog Number: 1016
• 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 15 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22110161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082285

FDA Product Code

• EBD: Coating, Filling Material, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-13
• Device Publish Date: 2019-06-05

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