GrandioSO 4U 6283

GUDID E22162831

light-curing, radiopaque nano-hybrid universal composite, Kit 5x4.5g

VOCO GmbH

Dental composite resin

• Primary Device ID: E22162831
• NIH Device Record Key: b064fb60-69e1-4503-85f1-91978e372bbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GrandioSO 4U
• Version Model Number: 6283
• Catalog Number: 6283
• 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
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22162831 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2025-06-10
• Device Publish Date: 2025-06-02

On-Brand Devices [GrandioSO 4U]

• E22163021: light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.4g, BL
• E22163011: light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.4g, opaque
• E22163001: light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.4g, A4
• E22162991: light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.4g, A3.5
• E22162981: light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.4g, A3
• E22162971: light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.4g, A2
• E22162961: light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.4g, A1
• E22162951: light-curing, radiopaque nano-hybrid universal composite, Kit Caps 75x0.4g
• E22162901: light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, BL
• E22162891: light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, opaque
• E22162881: light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A4
• E22162871: light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3.5
• E22162861: light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3
• E22162851: light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A2
• E22162841: light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A1
• E22162831: light-curing, radiopaque nano-hybrid universal composite, Kit 5x4.5g
• E22162821: light-curing, radiopaque nano-hybrid universal composite