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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / April 2026 / K260722

510(k) cleared

SureSmile Aligner (ASSY500020)

Dentsply Sirona, Inc. · Apr 15, 2026 · K260722

FDA cleared the SureSmile Aligner (ASSY500020) from Dentsply Sirona, Inc. on Apr 15, 2026 under K260722, a traditional 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 5, 2026. The decision came 41 days later, inside the 90 FDA-day goal for a 510(k).

Dentsply Sirona, Inc. has 8 other decisions in the tracker over the last 12 months: K261935 (Surgical and Prosthetic Trays), K262127 (DS Core CBCT Anatomy), K260785 (DS Core CBCT Anatomy), K253565 (SureSmile Software).

Questions & Answers

What did FDA clear under K260722?

K260722 is the FDA 510(k) for SureSmile Aligner (ASSY500020), submitted by Dentsply Sirona, Inc.. FDA's decision date was Apr 15, 2026, under product code NXC (Aligner, Sequential).

Who makes the SureSmile Aligner (ASSY500020)?

Dentsply Sirona, Inc., based in York, PA, is the applicant of record for K260722.

How long did the K260722 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on Apr 15, 2026, 41 days later.

← All decisions in April 2026