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FDA 510(k)

ATLANTIS suprastructures

K-Number: K163398 · 2017-08-14

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

Device Summary

ATLANTIS suprastructures is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2017-08-14 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K163398.

When did ATLANTIS suprastructures receive FDA 510(k) clearance?

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

Who is the listed applicant for ATLANTIS suprastructures?

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 suprastructures?

The FDA product code for ATLANTIS suprastructures 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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