HYGENIC® GuttaFlow®2 60013710

GUDID E165600137100

The HYGENIC® GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + Stops (20 pcs), 1 x Adapters for RotoMix™( 3 pcs), 1 x Dispenser, 1 x HYGENIC® Gutta Percha Points ISO 15-40 sample (100 pcs) and 1 x HYGENIC® Spectra Point® Gutta Percha Points Greater Taper 0.04 20-45 sample (60 pcs).

Coltène/Whaledent GmbH + Co. KG

Endodontic filling/sealing material

• Primary Device ID: E165600137100
• NIH Device Record Key: fda710e6-1880-4d1b-9e83-24e9b48dc5bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYGENIC® GuttaFlow®2
• Version Model Number: INTROKIT
• Catalog Number: 60013710
• 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: 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	E165600137100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032662

FDA Product Code

• EKM: Gutta-Percha

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: 2016-09-23

On-Brand Devices [HYGENIC® GuttaFlow®2]

• E165600137460: REFILL PACK DUAL-BARREL SYRING
• E165600137130: REFILL PACK CAPSULES FAST
• E165600137110: REFILL PACK CAPSULES REGULAR
• E165600137100: The HYGENIC® GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips
• E165600137090: STANDARD SET