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FDA 510(k)

E-connect S Endo Motor with built-in Apex Locator

K-Number: K201993 · 2021-01-29

ApplicantChangzhou Sifary Medical Technology Co., Ltd.
Decision Date2021-01-29
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

E-connect S Endo Motor with built-in Apex Locator is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201993. 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 E-connect S Endo Motor with built-in Apex Locator?

E-connect S Endo Motor with built-in Apex Locator is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K201993.

When did E-connect S Endo Motor with built-in Apex Locator receive FDA 510(k) clearance?

E-connect S Endo Motor with built-in Apex Locator received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201993.

Who is the listed applicant for E-connect S Endo Motor with built-in Apex Locator?

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

What is the FDA product code for E-connect S Endo Motor with built-in Apex Locator?

The FDA product code for E-connect S Endo Motor with built-in Apex Locator is EKX.

Related Clinical Trials

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.

NCT07526818Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator.ACTIVE_NOT_RECRUITINGNCT07527897Effect of Integrated Apex Locator Motor Modes on Postoperative Pain in Endodontic RetreatmentCOMPLETED

Other records listing Changzhou Sifary Medical 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.

K252224Apex Locator (FindPex)K232068HyperLight Portable X-ray UnitK221152CuringPen Dental Curing Light

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.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 Headquarters

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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