Dentsply International - FDA 510(k) Cleared Devices

Dentsply International is an American dental equipment manufacturer and consumables producer headquartered in York, US. The company designs and manufactures laboratory and specialty products for dental applications, serving markets in over 120 countries.

Dentsply International has received 23 FDA 510(k) clearances from 23 total submissions, with all submissions focused on dental devices. The company's regulatory clearance activity spans from 2001 to 2012, establishing a historical record in the dental device sector. No submissions were denied.

The company's cleared device portfolio reflects expertise in restorative materials, adhesive systems, curing lights, implant components, and orthodontic systems. Notable cleared products include universal dental adhesives, ceramic restoratives, LED curing lights, and dental implant abutments. This product range demonstrates the company's focus on both clinical and laboratory dental applications.

Explore the complete list of device names, product codes, and individual clearance dates in the database records below.