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 a medical device manufactured by Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-02-19 under approval 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. It is manufactured by Dentsply International, Inc.. The 510(k) number is K151439.
When was ATLANTIS ISUS approved by the FDA?
ATLANTIS ISUS received FDA 510(k) clearance on 2016-02-19, under approval number K151439.
What company makes ATLANTIS ISUS?
ATLANTIS ISUS is manufactured by Dentsply International, Inc..
What is the FDA product code for ATLANTIS ISUS?
The FDA product code for ATLANTIS ISUS 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.