Rebilda DC 1405

GUDID E22114051

Dual-curing flowable core build-up and post luting system

VOCO GmbH

Dental composite resin

• Primary Device ID: E22114051
• NIH Device Record Key: 28e1c286-8c70-44f7-a109-9f3ce2ffe914
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebilda DC
• Version Model Number: 1405
• Catalog Number: 1405
• 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	E22114051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060893

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 [Rebilda DC]

• E22114051: Dual-curing flowable core build-up and post luting system
• E22114041: Dual-curing flowable core build-up and post luting system
• E22114031: Dual-curing flowable core build-up and post luting system
• E22114021: Rebilda DC is a dual-curing, radiopaque, flowable composite indicated for core build-ups
• E22113981: Dual-curing flowable core build-up and post luting system
• E22113971: Dual-curing flowable core build-up and post luting system
• E22113961: Dual-curing flowable core build-up and post luting system
• E22113951: Rebilda DC is a dual-curing, radiopaque, flowable composite indicated for core build-ups
• E22114061: Dual-curing flowable core build-up and post luting system
• E22113991: Dual-curing flowable core build-up and post luting system