XSmart iQ— 510(k) K161213

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K161213 for XSmart iQ, Substantially Equivalent on 2017-02-10. Applicant: Dentsply Sirona. Device class: 1.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2016-04-29
Decision date: 2017-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.