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FDA 510(k)

ATLANTIS Crown

K-Number: K152247 · 2016-01-29

ApplicantDentsply International, Inc.
Decision Date2016-01-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS Crown is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K152247. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLANTIS Crown?

ATLANTIS Crown is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Dentsply International, Inc.. The 510(k) number is K152247.

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

ATLANTIS Crown received FDA 510(k) clearance on 2016-01-29, under 510(k) number K152247.

Who is the listed applicant for ATLANTIS Crown?

The FDA 510(k) record lists Dentsply International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATLANTIS Crown?

The FDA product code for ATLANTIS Crown is EIH.

Other records listing Dentsply International, Inc. as applicant

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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.

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