Atlantis® Abutments in Titanium
K-Number: K250081 · 2025-04-11
ApplicantDentsply Sirona
Decision Date2025-04-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Atlantis® Abutments in Titanium is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2025-04-11 under approval number K250081. 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® Abutments in Titanium?
Atlantis® Abutments in Titanium is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Dentsply Sirona. The 510(k) number is K250081.
When was Atlantis® Abutments in Titanium approved by the FDA?
Atlantis® Abutments in Titanium received FDA 510(k) clearance on 2025-04-11, under approval number K250081.
What company makes Atlantis® Abutments in Titanium?
Atlantis® Abutments in Titanium is manufactured by Dentsply Sirona.
What is the FDA product code for Atlantis® Abutments in Titanium?
The FDA product code for Atlantis® Abutments in Titanium 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.