ROEKO GuttaFlow®2 60019529

GUDID E165600195290

Coltène/Whaledent GmbH + Co. KG

Endodontic filling/sealing material

• Primary Device ID: E165600195290
• NIH Device Record Key: de35b4c2-8767-437d-a5be-955cfcf799c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROEKO GuttaFlow®2
• Version Model Number: SAMPLE
• Catalog Number: 60019529
• 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: 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: +4973458050
• Email: info.de@coltene.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E165600195290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032662

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: 2016-08-23

On-Brand Devices [ROEKO GuttaFlow®2]

• E165600195290: SAMPLE
• E165600137450: REFILL PACK DUAL-BARREL SYRING
• E165600137060: REFILL PACK CAPSULES FAST
• E165600137040: REFILL PACK CAPSULES REGULAR
• E165600137020: The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + St
• E165600137010: STANDARD SET
• E165600137190: ROEKO GuttaFlow®2 Mixing tips