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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K252343

510(k) cleared

Atlantis® Abutments in Titanium

Dentsply Sirona · Dec 9, 2025 · K252343

FDA cleared the Atlantis® Abutments in Titanium from Dentsply Sirona on Dec 9, 2025 under K252343, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 28, 2025. The decision came 134 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Dentsply Sirona has 8 other decisions in the tracker over the last 12 months: K260785 (DS Core CBCT Anatomy), K260722 (SureSmile Aligner (ASSY500020)), K253565 (SureSmile Software), K251614 (Stainless Steel Surgical Kits).

Questions & Answers

What did FDA clear under K252343?

K252343 is the FDA 510(k) for Atlantis® Abutments in Titanium, submitted by Dentsply Sirona. FDA's decision date was Dec 9, 2025, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the Atlantis® Abutments in Titanium?

Dentsply Sirona, based in York, PA, is the applicant of record for K252343.

How long did the K252343 review take?

FDA received the submission on Jul 28, 2025 and issued its decision on Dec 9, 2025, 134 days later.

← All decisions in December 2025