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FDA 510(k)

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

K-Number: K242514 · 2025-04-24

ApplicantShenzhen Rogin Medical Co., Ltd.
Decision Date2025-04-24
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K242514. 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 Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. The 510(k) number is K242514.

When did Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) receive FDA 510(k) clearance?

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242514.

Who is the listed applicant for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?

The FDA 510(k) record lists Shenzhen Rogin Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?

The FDA product code for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is EKX.

Other records listing Shenzhen Rogin Medical 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.

K242383Apex Locator

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.

K252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.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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