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FDA 510(k)

ATLANTIS Conus Structure

K-Number: K181189 · 2018-07-18

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

Device Summary

ATLANTIS Conus Structure is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2018-07-18 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K181189.

When did ATLANTIS Conus Structure receive FDA 510(k) clearance?

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

Who is the listed applicant for ATLANTIS Conus Structure?

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 ATLANTIS Conus Structure?

The FDA product code for ATLANTIS Conus Structure is NHA.

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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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