Quick Up 1628

GUDID E22116281

VOCO GmbH

Denture reliner, hard

• Primary Device ID: E22116281
• NIH Device Record Key: 237133ef-a151-4cf1-b0da-0499f5e91063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick Up
• Version Model Number: 1628
• Catalog Number: 1628
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 1
• 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	E22116281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110440

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-08-02

On-Brand Devices [Quick Up]

• E22116281: 1628
• E22116261: Self-curing luting material for attachments and secondary denture parts