OdneClean
FDA 510(k) K233844 · Odne AG
510(k) numberK233844
Submission
- Device name
- OdneClean
- Applicant
- Odne AG
Dübendorf, CH - Received
- December 4, 2023
- Decision date
- August 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260773 | Varios Combi Pro2ELC · Traditional | Nakanishi, Inc. | 03/10/2026SE |
| K253254 | GBT Machine Airflow Prophylaxis MasterELC · Traditional | E.M.S Electro Medical Systems S.A | 01/28/2026SE |
| K251689 | Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11)…ELC · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K242317 | Integrated Endo System (Meet Endo-II)ELC · Traditional | Denjoy Dental Co., Ltd. | 02/13/2025SE |
| K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-J…ELC · Traditional | Shenzhen Micro Electric Intelligence Co., Ltd. | 07/02/2024SE |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537)ELC · Traditional | Dent4you AG | 07/01/2024SE |
| K233922 | SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3…ELC · Traditional | Satelec - Acteon Group | 03/11/2024SE |
| K223340 | EDS Calculus Softener TURBO CRELC · Traditional | Essential Dental Systems, Inc. | 12/11/2023SE |
| K230641 | Ultrasonic Scaler TipsELC · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 11/21/2023SE |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530)ELC · Traditional | W&H Dentalwerk Buermoss GmbH | 07/14/2023SE |
Questions and answers
When was OdneClean cleared by the FDA?
OdneClean (K233844) received a 510(k) decision of Substantially Equivalent on August 8, 2024, 248 days after the submission was received.
What is the product code of K233844?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.