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FDA 510(k)

Alpha Endo Handpiece (Alpha Endo)

K-Number: K252223 · 2025-10-16

ApplicantSHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Decision Date2025-10-16
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Alpha Endo Handpiece (Alpha Endo) is the device name listed in this FDA 510(k) record. The listed applicant is SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. It received FDA 510(k) clearance on 2025-10-16 under 510(k) 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. The listed applicant is SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. The 510(k) number is K252223.

When did Alpha Endo Handpiece (Alpha Endo) receive FDA 510(k) clearance?

Alpha Endo Handpiece (Alpha Endo) received FDA 510(k) clearance on 2025-10-16, under 510(k) number K252223.

Who is the listed applicant for Alpha Endo Handpiece (Alpha Endo)?

The FDA 510(k) record lists SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

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 records listing SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242765Electronic Apex Locator (Alpha Apex I)

Related Devices (Code: EKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.K243911HPR Cordless Hygiene HandpieceHandpiece HeadquartersK222688The TrustGenoss Co., Ltd.

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.

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