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FDA 510(k)

Navina Classic System

K-Number: K170487 · 2017-09-11

ApplicantDentsply Sirona
Decision Date2017-09-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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 2017-09-11 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K170487.

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

Navina Classic System received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170487.

Who is the listed applicant for 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 Classic System?

The FDA product code for 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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