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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 a medical device manufactured by Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under approval 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. It is manufactured by Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K201993.

When was E-connect S Endo Motor with built-in Apex Locator approved by the FDA?

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

What company makes E-connect S Endo Motor with built-in Apex Locator?

E-connect S Endo Motor with built-in Apex Locator is manufactured by Changzhou Sifary Medical Technology Co., Ltd..

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

NCT07526818 Comparison 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_RECRUITING NCT07357428 Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) RECRUITING NCT07527897 Effect of Integrated Apex Locator Motor Modes on Postoperative Pain in Endodontic Retreatment COMPLETED

Other Devices by Changzhou Sifary Medical Technology Co., Ltd.

K221152CuringPen Dental Curing Light K232068HyperLight Portable X-ray Unit K252224Apex Locator (FindPex)

Related Devices (Code: EKX)

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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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