Grandio 1842

GUDID E22118421

Excellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high abrasion resistance. High transverse strength. Smooth consistency for convenient handling. Shade guide made from original material.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22118421
• NIH Device Record Key: c72c65fe-cb4a-4d10-8fcc-ab7417aa682d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grandio
• Version Model Number: 1842
• Catalog Number: 1842
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 20
• 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	E22118420 [Unit of Use]
HIBCC	E22118421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051867

FDA Product Code

• EBF: Material, Tooth Shade, 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

On-Brand Devices [Grandio]

• E22118551: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118541: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118531: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118521: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118511: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118501: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118491: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118481: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118471: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118461: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118451: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118441: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118431: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118421: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118411: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118401: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118381: Universal nano-hybrid restorative material.
• E22118301: Universal nano-hybrid restorative material. The kit contains different shades of Grandio.
• E22118251: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118241: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118231: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118221: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118211: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118201: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118191: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118181: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118171: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118161: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118151: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118141: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118131: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118121: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118111: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118101: Excellent physical properties for long-lasting restorations. Significantly lower polymerisation
• E22118081: Universal nano-hybrid restorative material.
• E22118051: Universal nano-hybrid restorative material.
• E22118001: Universal nano-hybrid restorative material. The kit contains different shades of Grandio.