ROEKO RoekoSeal Automix 349100

GUDID E1653491000

Coltène/Whaledent GmbH + Co. KG

Endodontic filling/sealing material

• Primary Device ID: E1653491000
• NIH Device Record Key: fd196c12-cc26-4cc3-a8c0-2bf57f57f90d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROEKO RoekoSeal Automix
• Version Model Number: Set
• Catalog Number: 349100
• Company DUNS: 315494443
• Company Name: Coltène/Whaledent 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: true
• 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: +4973458050
• Email: info.de@coltene.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E1653491000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983037

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2016-12-29

On-Brand Devices [ROEKO RoekoSeal Automix]

• E1653491020: Refill pack Dual-barrel syringe
• E1653491000: Set