OdneCure E-0001

GUDID 07649988156694

1 OdneCure Root Canal Cleaning Device consisting of Charging stand, 2 batteries, body of the lamp, packaged with Cable, Plug, 500 Sleeves, IFU, quick guide

Odne AG

Dental/surgical polymerization lamp

• Primary Device ID: 07649988156694
• NIH Device Record Key: d89902da-68cc-4148-81cb-354416d2f27e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OdneCure
• Version Model Number: E-0001
• Catalog Number: E-0001
• Company DUNS: 480237899
• Company Name: Odne AG
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	07649988156694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232076

FDA Product Code

• QNF: Laser Activator For Polymerization

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

• 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: 2024-02-091 OdneCure Root Canal Cleaning Device consisting of Charging stand, 2 batteries, body of the lamp, packaged with Cable, Plug, 500 Sleeves, IFU, quick guide
• 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