K230641 is an FDA 510(k) clearance for the Ultrasonic Scaler Tips. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Guilin Refine Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on November 21, 2023, 258 days after receiving the submission on March 8, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K230641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2023 |
| Decision Date | November 21, 2023 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC - Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |