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FDA 510(k)

Navina Smart System, Navina Classic System

K-Number: K190977 · 2019-11-22

ApplicantDentsply Sirona
Decision Date2019-11-22
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Navina Smart System, Navina Classic System is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K190977. 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 Smart System, Navina Classic System?

Navina Smart System, Navina Classic System is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Dentsply Sirona. The 510(k) number is K190977.

When did Navina Smart System, Navina Classic System receive FDA 510(k) clearance?

Navina Smart System, Navina Classic System received FDA 510(k) clearance on 2019-11-22, under 510(k) number K190977.

Who is the listed applicant for Navina Smart System, Navina Classic System?

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 Navina Smart System, Navina Classic System?

The FDA product code for Navina Smart System, Navina Classic System is KNT.

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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.

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