GrandioSO x-tra 2714

GUDID E22127141

GrandioSO x-tra Caps 16x0.25g U GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterised by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22127141
• NIH Device Record Key: f8e1ea1f-a7fe-47f0-b08e-a3a980010119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GrandioSO x-tra
• Version Model Number: 2714
• Catalog Number: 2714
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22127140 [Unit of Use]
HIBCC	E22127141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181312

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: 2018-10-01
• Device Publish Date: 2018-08-29

On-Brand Devices [GrandioSO x-tra ]

• E22127191: GrandioSO x-tra Caps 80x0.25g A3 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restor
• E22127171: GrandioSO x-tra Caps 16x0.25g A3 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restor
• E22127161: GrandioSO x-tra Caps 16x0.25g A2 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restor
• E22127151: GrandioSO x-tra Caps 16x0.25g A1 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid resto
• E22127141: GrandioSO x-tra Caps 16x0.25g U GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restor
• E22125991: Syringe 5x4g A3 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material.
• E22125981: Syringe 4g A3 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It
• E22125971: Syringe 4g A2 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It
• E22125961: Syringe 4g A1 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It
• E22125951: Syringe 4g U GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It