K252223 is an FDA 510(k) clearance for the Alpha Endo Handpiece (Alpha Endo). This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2025, 92 days after receiving the submission on July 16, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K252223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2025 |
| Decision Date | October 16, 2025 |
| Days to Decision | 92 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 |