VisCalor bulk

GUDID E22160661

VOCO GmbH

Dental composite resin

• Primary Device ID: E22160661
• NIH Device Record Key: bf045cc0-3ca4-4505-96cb-8229ee079f96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisCalor bulk
• Version Model Number: 6066
• 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	E2216066 [Unit of Use]
HIBCC	E22160661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190453

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: 2019-05-09
• Device Publish Date: 2019-05-01

On-Brand Devices [VisCalor bulk]

• E22160681: 6068
• E22160671: 6067
• E22160661: 6066
• E22160651: 6065
• E22160631: set contains Caps Sticks A1, A2, A3, uni, Caps Warmer
• E22160621: set contains Caps Sticks A1, A2, A3, uni, VisCalor Dispenser