510(k) K252223
K252223 is an FDA 510(k) premarket notification submitted by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. for the device "Alpha Endo Handpiece (Alpha Endo)". The FDA issued a decision of Substantially Equivalent on October 16, 2025. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2025
- Date Received
- July 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type