Grandio Seal 1061

GUDID E22110611

Grandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant with outstanding mechanical properties.

VOCO GmbH

Dental unfilled resin sealant/coating

• Primary Device ID: E22110611
• NIH Device Record Key: 1e87cf4a-f589-4146-bc8b-1ed7cda8db34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grandio Seal
• Version Model Number: 1061
• Catalog Number: 1061
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 2
• 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	E2211061 [Unit of Use]
HIBCC	E22110611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062344

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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

On-Brand Devices [Grandio Seal]

• E22110611: Grandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant
• E22110601: Grandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant