Grandio SO Heavy Flow 2712

GUDID E22127121

Flowable universal nano-hybrid restorative material - highly viscous

VOCO GmbH

Dental composite resin

• Primary Device ID: E22127121
• NIH Device Record Key: 3abb4dff-cb66-4065-a5d1-eaee17ab021b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grandio SO Heavy Flow
• Version Model Number: 2712
• Catalog Number: 2712
• 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	E22127120 [Unit of Use]
HIBCC	E22127121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102354

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 Heavy Flow]

• E22127201: Flowable universal nano-hybrid restorative material - highly viscous. The kit contains different
• E22127121: Flowable universal nano-hybrid restorative material - highly viscous
• E22127081: Flowable universal nano-hybrid restorative material - highly viscous
• E22127071: Flowable universal nano-hybrid restorative material - highly viscous
• E22127061: Flowable universal nano-hybrid restorative material - highly viscous
• E22127051: Flowable universal nano-hybrid restorative material - highly viscous
• E22127041: Flowable universal nano-hybrid restorative material - highly viscous
• E22126991: Flowable universal nano-hybrid restorative material - highly viscous
• E22126961: Flowable universal nano-hybrid restorative material - highly viscous
• E22126951: Flowable universal nano-hybrid restorative material - highly viscous
• E22126941: Flowable universal nano-hybrid restorative material - highly viscous
• E22126931: Flowable universal nano-hybrid restorative material - highly viscous
• E22126921: Flowable universal nano-hybrid restorative material - highly viscous
• E22126911: Flowable universal nano-hybrid restorative material - highly viscous
• E22126901: Flowable universal nano-hybrid restorative material - highly viscous
• E22126891: Flowable universal nano-hybrid restorative material - highly viscous
• E22126881: Flowable universal nano-hybrid restorative material - highly viscous
• E22126871: Flowable universal nano-hybrid restorative material - highly viscous
• E22126861: Flowable universal nano-hybrid restorative material - highly viscous
• E22126851: Flowable universal nano-hybrid restorative material - highly viscous
• E22126841: Flowable universal nano-hybrid restorative material - highly viscous
• E22126801: Flowable universal nano-hybrid restorative material - highly viscous