GrandioSO Light Flow 2585

GUDID E2212585

highly flowable, light-curing, radiopaque nano-hybrid restorative material The set contains 5 different shades of GrandioSOFlow, a shade guide and application cannulas type 44 and type 45.

VOCO GmbH

Dental composite resin

• Primary Device ID: E2212585
• NIH Device Record Key: 89b39789-a096-40f8-ac52-fe9a5c66d90a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GrandioSO Light Flow
• Version Model Number: 2585
• Catalog Number: 2585
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	E2212585 [Unit of Use]
HIBCC	E22125851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200294

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: 2020-04-08
• Device Publish Date: 2020-03-31

On-Brand Devices [GrandioSO Light Flow]

• E2212593: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour Incisal (I)
• E2212592: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour OA2
• E2212591: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour WO
• E2212590: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour B1
• E2212589: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3.5
• E2212588: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3
• E2212587: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A2
• E2212586: highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A1
• E2212585: highly flowable, light-curing, radiopaque nano-hybrid restorative material The set contains 5 di