Atlantis® Abutments in Titanium
K-Number: K252343 · 2025-12-09
ApplicantDentsply Sirona
Decision Date2025-12-09
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 2025-12-09 under approval number K252343. 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 2025-12-09. It is manufactured by Dentsply Sirona. The 510(k) number is K252343.
When was Atlantis® Abutments in Titanium approved by the FDA?
Atlantis® Abutments in Titanium received FDA 510(k) clearance on 2025-12-09, under approval number K252343.
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.
Other Devices by Dentsply Sirona
Related Devices (Code: NHA)
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.
K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.
K161435Temporary Snap AbutmentNobel Biocare AB
K160786RODO Abutment SystemRodo Medical, Inc.
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.