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FDA 510(k)

XSmart iQ

K-Number: K161213 · 2017-02-10

ApplicantDentsply Sirona
Decision Date2017-02-10
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XSmart iQ is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K161213. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XSmart iQ?

XSmart iQ is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Dentsply Sirona. The 510(k) number is K161213.

When did XSmart iQ receive FDA 510(k) clearance?

XSmart iQ received FDA 510(k) clearance on 2017-02-10, under 510(k) number K161213.

Who is the listed applicant for XSmart iQ?

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

What is the FDA product code for XSmart iQ?

The FDA product code for XSmart iQ is EBW.

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Related Devices (Code: EBW)

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.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

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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