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FDA 510(k)

X-SMART EASY

K-Number: K092614 · 2009-12-02

ApplicantDentsply Interntional
Decision Date2009-12-02
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-SMART EASY is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2009-12-02 under 510(k) number K092614. 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 X-SMART EASY?

X-SMART EASY is a medical device that received FDA 510(k) clearance on 2009-12-02. The listed applicant is Dentsply Interntional. The 510(k) number is K092614.

When did X-SMART EASY receive FDA 510(k) clearance?

X-SMART EASY received FDA 510(k) clearance on 2009-12-02, under 510(k) number K092614.

Who is the listed applicant for X-SMART EASY?

The FDA 510(k) record lists Dentsply Interntional as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-SMART EASY?

The FDA product code for X-SMART EASY is EKX.

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Other records listing Dentsply Interntional as applicant

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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.

K261987Reusable SmartPegOsstell ABK252223Alpha 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.

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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