Remin Pro 2009

GUDID E22120091

Protective dental care with fluoride and hydroxy apatit

VOCO GmbH

Dentifrice

• Primary Device ID: E22120091
• NIH Device Record Key: 29314675-036b-4cf0-b732-21b509c365b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remin Pro
• Version Model Number: 2009
• Catalog Number: 2009
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 2
• 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	E2212009 [Unit of Use]
HIBCC	E22120091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101104

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral Cavity

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: 2019-06-14
• Device Publish Date: 2019-06-06

On-Brand Devices [Remin Pro]

• E22120091: Protective dental care with fluoride and hydroxy apatit
• E22120071: Protective dental care with fluoride and hydroxy apatit
• E22120061: Protective dental care with fluoride and hydroxy apatit
• E22120051: Protective dental care with fluoride and hydroxy apatit
• E22120041: Protective dental care with fluoride and hydroxy apatit
• E22120031: Protective dental care with fluoride and hydroxy apatit