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The Tracker / August 2026 / K262127

510(k) cleared

DS Core CBCT Anatomy

Dentsply Sirona · Aug 21, 2026 · K262127

FDA cleared the DS Core CBCT Anatomy from Dentsply Sirona on Aug 21, 2026 under K262127, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 24, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

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 K262127?

K262127 is the FDA 510(k) for DS Core CBCT Anatomy, submitted by Dentsply Sirona. FDA's decision date was Aug 21, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the DS Core CBCT Anatomy?

Dentsply Sirona, based in York, PA, is the applicant of record for K262127.

How long did the K262127 review take?

FDA received the submission on Jun 24, 2026 and issued its decision on Aug 21, 2026, 58 days later.

← All decisions in August 2026