OdneFill Tip E-8000

GUDID 07649988072475

OdneFill tip, 10 pieces, not sterile, for application of OdneFill endodontic obturation material

Odne AG

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• Primary Device ID: 07649988072475
• NIH Device Record Key: ce0919ba-5cb9-462b-bded-d4d6c4a28dbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OdneFill Tip
• Version Model Number: E-8000
• Catalog Number: E-8000
• Company DUNS: 480237899
• Company Name: Odne AG
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07649988072413 [Unit of Use]
GS1	07649988072451 [Primary]
GS1	07649988072475 [Package]; Contains: 07649988072451; Package: [40 Units]; In Commercial Distribution

FDA Product Code

• EIY: Instrument, Filling, Plastic, Dental

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: 2024-02-09
• Device Publish Date: 2024-02-01

Devices Manufactured by Odne AG

• 07649988072406 - OdneCure Tip: 2024-02-12 Optical Fiber Curing Tip for use with OdneCure device
• 07649988072475 - OdneFill Tip: 2024-02-09OdneFill tip, 10 pieces, not sterile, for application of OdneFill endodontic obturation material
• 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: 2024-02-08 OdneFill Endodontic Filler, 10x 0.2 ml, Box of 10 syringes. Hydrophilic, radiopaque, light-curable endodontic sealer, consisting