VisCalor 6113

GUDID E22161130

VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22161130
• NIH Device Record Key: 7df149fa-a979-4fe1-9f8d-3297d72a86a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisCalor
• Version Model Number: 6113
• Catalog Number: 6113
• 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: true
• 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	E22161130 [Unit of Use]
HIBCC	E22161131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201307

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: 2020-07-30
• Device Publish Date: 2020-07-22

On-Brand Devices [VisCalor]

• E22161230: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161220: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161210: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161200: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161190: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161180: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161170: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161160: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161150: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161140: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161130: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E22161101: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E221610910: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
• E221610810: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Futurabon
• E221610710: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Caps Warm
• E22161060: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains VisCalor