Axeos
K-Number: K201140 · 2020-06-22
ApplicantDentsply Sirona
Decision Date2020-06-22
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Axeos is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2020-06-22 under approval 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. It is manufactured by Dentsply Sirona. The 510(k) number is K201140.
When was Axeos approved by the FDA?
Axeos received FDA 510(k) clearance on 2020-06-22, under approval number K201140.
What company makes Axeos?
Axeos is manufactured by Dentsply Sirona.
What is the FDA product code for Axeos?
The FDA product code for Axeos is OAS.
Other Devices by Dentsply Sirona
Related Devices (Code: OAS)
K161900HYPERION X5Cefla S.C.
K160166X-MIND triumDe Gotzen S.R.L.
K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International
K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.
K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.
K161881PreXion3D ExcelsiorPrexion Corporation
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.