Submission Details
| 510(k) Number | K233844 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 04, 2023 |
| Decision Date | August 08, 2024 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
OdneClean
Aug 2024
Decision
248d
Days
Class 2
Risk
About This 510(k) Submission
K233844 is an FDA 510(k) clearance for the OdneClean, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Odne AG (D?bendorf, CH). The FDA issued a Cleared decision on August 8, 2024, 248 days after receiving the submission on December 4, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.
Device Classification
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4850 |
Manufacturer
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