Data / Medical devices / Switzerland / Odne AG
Odne AG: FDA-registered device maker in Dubendorf Zurich, Switzerland, 3 510(k) clearances
Odne AG is registered with the FDA (registration 3030405669) in Dubendorf Zurich, Switzerland. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030405669
- Address
- Ringstrasse 14, Dubendorf Zurich, Switzerland, 8600
- Owner or operator
- Odne AG (10089937)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 24, 2024
- Registered through
- 2026
- Brand names listed
- OdneClean, OdneClean Tip, OdneCure, OdneCure Tip, OdneFill, OdneFill Tip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Filling, Plastic, Dental | EIY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laser Activator For Polymerization | QNF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2024 | K233844 | OdneClean | ELC | Substantially Equivalent | Odne AG | accessdata.fda.gov |
| November 2, 2023 | K232076 | Fibercure | QNF | Substantially Equivalent | Lumendo AG | accessdata.fda.gov |
| July 10, 2023 | K231387 | Endofill | KIF | Substantially Equivalent | Lumendo AG | accessdata.fda.gov |
Compare with other makers
- All makers of Scaler, Ultrasonic
- All makers of Instrument, Filling, Plastic, Dental
- All makers of Laser Activator For Polymerization
- All makers of Resin, Root Canal Filling
Updated August 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.