510(k) K233844
K233844 is an FDA 510(k) premarket notification submitted by Odne AG for the device "OdneClean". The FDA issued a decision of Substantially Equivalent on August 8, 2024. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2024
- Date Received
- December 4, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type