| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07649988156694 [Primary] |
| QNF | Laser Activator For Polymerization |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-09 |
| Device Publish Date | 2024-02-01 |
| 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 |