OdneFill E-0002

GUDID 07649988156649

OdneFill Endodontic Filler, 10x 0.2 ml, Box of 10 syringes. Hydrophilic, radiopaque, light-curable endodontic sealer, consisting of a liquid, highly flowable material to be applied into the prepared and cleaned root canal and converted into a solid polymer by photocuring. One-material obturation solution that does not require gutta-percha points.

Odne AG

Dental composite resin

• Primary Device ID: 07649988156649
• NIH Device Record Key: d2dd75ae-5cd3-4463-a0cf-a5c3542a2372
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OdneFill
• Version Model Number: E-0002
• Catalog Number: E-0002
• Company DUNS: 480237899
• Company Name: Odne AG
• Device Count: 10
• 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: true
• 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: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co
• Phone: +41445896803
• Email: info@odne.co

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07649988072437 [Package]; Contains: 07649988156618; Package: [40 Units]; In Commercial Distribution
GS1	07649988156618 [Primary]
GS1	07649988156649 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231387

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-08
• Device Publish Date: 2024-01-31

Devices Manufactured by Odne AG

• 07649988156632 - OdneClean: 2024-12-06 1 OdneClean Device containing hose, metal rod holder, handpiece, multiple connection hoses, hose for disinfection, plug and cabl
• 07649988072406 - OdneCure Tip: 2024-02-12 Optical Fiber Curing Tip for use with OdneCure device
• 07649988072475 - OdneFill Tip: 2024-02-09 OdneFill tip, 10 pieces, not sterile, for application of OdneFill endodontic obturation material
• 07649988156694 - OdneCure: 2024-02-09 1 OdneCure Root Canal Cleaning Device consisting of Charging stand, 2 batteries, body of the lamp, packaged with Cable, Plug, 50
• 07649988156649 - OdneFill: 2024-02-08OdneFill Endodontic Filler, 10x 0.2 ml, Box of 10 syringes. Hydrophilic, radiopaque, light-curable endodontic sealer, consisting of a liquid, highly flowable material to be applied into the prepared and cleaned root canal and converted into a solid polymer by photocuring. One-material obturation solution that does not require gutta-percha points.
• 07649988156649 - OdneFill: 2024-02-08 OdneFill Endodontic Filler, 10x 0.2 ml, Box of 10 syringes. Hydrophilic, radiopaque, light-curable endodontic sealer, consisting