Decision Date2017-09-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Navina Classic System is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2017-09-11 under approval number K170487. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Navina Classic System?
Navina Classic System is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by Dentsply Sirona. The 510(k) number is K170487.
When was Navina Classic System approved by the FDA?
Navina Classic System received FDA 510(k) clearance on 2017-09-11, under approval number K170487.
What company makes Navina Classic System?
Navina Classic System is manufactured by Dentsply Sirona.
What is the FDA product code for Navina Classic System?
The FDA product code for Navina Classic System is KNT.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.