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FDA 510(k)

ATLANTIS suprastructures

K-Number: K163398 · 2017-08-14

Decision Date2017-08-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS suprastructures is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2017-08-14 under approval number K163398. 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 suprastructures?

ATLANTIS suprastructures is a medical device that received FDA 510(k) clearance on 2017-08-14. It is manufactured by Dentsply Sirona. The 510(k) number is K163398.

When was ATLANTIS suprastructures approved by the FDA?

ATLANTIS suprastructures received FDA 510(k) clearance on 2017-08-14, under approval number K163398.

What company makes ATLANTIS suprastructures?

ATLANTIS suprastructures is manufactured by Dentsply Sirona.

What is the FDA product code for ATLANTIS suprastructures?

The FDA product code for ATLANTIS suprastructures is NHA.

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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.