K233865 is an FDA 510(k) clearance for the X-Smart Pro. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on July 24, 2024, 231 days after receiving the submission on December 6, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K233865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2023 |
| Decision Date | July 24, 2024 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX — Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |