Alpha Endo Handpiece (Alpha Endo)
K-Number: K252223 · 2025-10-16
Decision Date2025-10-16
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Alpha Endo Handpiece (Alpha Endo) is a medical device manufactured by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. It received FDA 510(k) clearance on 2025-10-16 under approval number K252223. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alpha Endo Handpiece (Alpha Endo)?
Alpha Endo Handpiece (Alpha Endo) is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. The 510(k) number is K252223.
When was Alpha Endo Handpiece (Alpha Endo) approved by the FDA?
Alpha Endo Handpiece (Alpha Endo) received FDA 510(k) clearance on 2025-10-16, under approval number K252223.
What company makes Alpha Endo Handpiece (Alpha Endo)?
Alpha Endo Handpiece (Alpha Endo) is manufactured by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD..
What is the FDA product code for Alpha Endo Handpiece (Alpha Endo)?
The FDA product code for Alpha Endo Handpiece (Alpha Endo) is EKX.
Other Devices by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Related Devices (Code: EKX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.