Mucopren 28105

GUDID E217281051

Mucopren Soft Basic Set

Kettenbach GmbH & Co. KG

Denture reliner, elastic, long-term

• Primary Device ID: E217281051
• NIH Device Record Key: cd9129f6-edcc-4077-8667-5e11d872367e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mucopren
• Version Model Number: 28105
• Catalog Number: 28105
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• 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: 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: +4927747050
• Email: info@kettenbach.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E217281051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983357

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: 2016-09-19

On-Brand Devices [Mucopren]

• E217281061: Mucopren Soft Basic Set + Applyfix 4 disp. gun
• E217281051: Mucopren Soft Basic Set
• E217156871: Mucopren Soft Normal pack
• E217156861: Mucopren silicone sealant Normal pack
• E217142031: Mucopren Adhesive