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510(k) K252223

Alpha Endo Handpiece (Alpha Endo) by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. — Product Code EKX

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

Other clearances by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

  • K242765 — Electronic Apex Locator (Alpha Apex I) (January 17, 2025)

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