Dentsply Sirona - FDA 510(k) Cleared Devices

Dentsply Sirona, is an American dental equipment manufacturer and consumables producer headquartered in York, US. The company markets products in over 120 countries and operates factories across 21 nations.

Dentsply Sirona has received 65 FDA 510(k) clearances from 65 total submissions since 2016. Dental devices represent 78% of the company's regulatory submissions, reflecting its core focus on laboratory equipment, specialty products, and consumables including abutments, CAD/CAM blocks, and restorative materials. The company's latest clearance in 2026 demonstrates continued regulatory activity and product innovation.

Dentsply Sirona specializes in dental supplies including anesthetics, prophylaxis products, tooth polishers, and artificial teeth. The company is recognized as a key player in intra-oral imaging technology and digital dentistry solutions. Its product portfolio spans both equipment and consumables serving dental laboratories and clinical practices worldwide.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.

510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.