Identium 14725

GUDID E217147251

Identium Heavy Refill pack

Kettenbach GmbH & Co. KG

Silicone dental impression material

• Primary Device ID: E217147251
• NIH Device Record Key: 0dcb1e48-e115-49b0-8e4f-3b75f148282f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identium
• Version Model Number: 14725
• Catalog Number: 14725
• 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	E217147251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092867

FDA Product Code

• ELW: Material, Impression

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: 2016-09-06

On-Brand Devices [Identium]

• E217147271: Identium Heavy Fast Refill pack
• E217147261: Identium Heavy Fast Intro pack
• E217147251: Identium Heavy Refill pack
• E217147241: Identium Heavy Intro pack
• E217147191: Identium Medium Fast Refill pack
• E217147181: Identium Medium Fast Intro pack
• E217147171: Identium Medium Refill pack
• E217147161: Identium Medium Intro pack
• E217137111: Identium Light Fast Normal pack
• E217137101: Identium Light Fast Sample
• E217137011: Identium Light Normal pack
• E217137001: Identium Light Sample
• E21713711111: Identium Light Fast Normal pack
• E21713701111: Identium Light Normal pack