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FDA 510(k)

ATLANTIS ISUS

K-Number: K151439 · 2016-02-19

ApplicantDentsply International, Inc.
Decision Date2016-02-19
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS ISUS 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 2016-02-19 under 510(k) number K151439. 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 ISUS?

ATLANTIS ISUS is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Dentsply International, Inc.. The 510(k) number is K151439.

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

ATLANTIS ISUS received FDA 510(k) clearance on 2016-02-19, under 510(k) number K151439.

Who is the listed applicant for ATLANTIS ISUS?

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 ISUS?

The FDA product code for ATLANTIS ISUS is NHA.

Other records listing Dentsply International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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