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 a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2017-02-10 under approval 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. It is manufactured by Dentsply Sirona. The 510(k) number is K161213.
When was XSmart iQ approved by the FDA?
XSmart iQ received FDA 510(k) clearance on 2017-02-10, under approval number K161213.
What company makes XSmart iQ?
XSmart iQ is manufactured by Dentsply Sirona.
What is the FDA product code for XSmart iQ?
The FDA product code for XSmart iQ is EBW.
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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.