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FDA 510(k)

ATLANTIS Conus Structure

K-Number: K181189 · 2018-07-18

Decision Date2018-07-18
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS Conus Structure is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-07-18 under approval number K181189. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLANTIS Conus Structure?

ATLANTIS Conus Structure is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Dentsply Sirona. The 510(k) number is K181189.

When was ATLANTIS Conus Structure approved by the FDA?

ATLANTIS Conus Structure received FDA 510(k) clearance on 2018-07-18, under approval number K181189.

What company makes ATLANTIS Conus Structure?

ATLANTIS Conus Structure is manufactured by Dentsply Sirona.

What is the FDA product code for ATLANTIS Conus Structure?

The FDA product code for ATLANTIS Conus Structure is NHA.

Other Devices by Dentsply Sirona

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Related Devices (Code: NHA)

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.