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FDA 510(k)

Axeos

K-Number: K201140 · 2020-06-22

ApplicantDentsply Sirona
Decision Date2020-06-22
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Axeos is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K201140. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axeos?

Axeos is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Dentsply Sirona. The 510(k) number is K201140.

When did Axeos receive FDA 510(k) clearance?

Axeos received FDA 510(k) clearance on 2020-06-22, under 510(k) number K201140.

Who is the listed applicant for Axeos?

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 Axeos?

The FDA product code for Axeos is OAS.

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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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