Grandio SO Flow 2744

GUDID E22127441

Flowable universal nano-hybrid restorative material

VOCO GmbH

Dental composite resin

• Primary Device ID: E22127441
• NIH Device Record Key: a52719c6-9132-419d-bd0e-f38e9eba4386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grandio SO Flow
• Version Model Number: 2744
• Catalog Number: 2744
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 16
• 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	E22127440 [Unit of Use]
HIBCC	E22127441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103580

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 SO Flow]

• E22127491: Flowable universal nano-hybrid restorative material
• E22127461: Flowable universal nano-hybrid restorative material
• E22127451: Flowable universal nano-hybrid restorative material
• E22127441: Flowable universal nano-hybrid restorative material
• E22127431: Flowable universal nano-hybrid restorative material
• E22127421: Flowable universal nano-hybrid restorative material
• E22127371: Flowable universal nano-hybrid restorative material
• E22127361: Flowable universal nano-hybrid restorative material
• E22127341: Flowable universal nano-hybrid restorative material
• E22127331: Flowable universal nano-hybrid restorative material
• E22127321: Flowable universal nano-hybrid restorative material
• E22127301: Flowable universal nano-hybrid restorative material
• E22127291: Flowable universal nano-hybrid restorative material
• E22127271: Flowable universal nano-hybrid restorative material
• E22127261: Flowable universal nano-hybrid restorative material
• E22127251: Flowable universal nano-hybrid restorative material
• E22127241: Flowable universal nano-hybrid restorative material
• E22127231: Flowable universal nano-hybrid restorative material
• E22127221: Flowable universal nano-hybrid restorative material