Alpha Endo Handpiece (Alpha Endo)— 510(k) K252223

Substantially Equivalent

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

FDA 510(k) clearance K252223 for Alpha Endo Handpiece (Alpha Endo), Substantially Equivalent on 2025-10-16. Applicant: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD..

Clearance details

Applicant: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Product code: Code EKX
Advisory panel: Dental
Date received: 2025-07-16
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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Data sourced from openFDA. This site is unofficial and independent of the FDA.