Henry Schein, Inc. - FDA 510(k) Cleared Devices

Henry Schein, Inc. is a global distributor of dental and medical supplies with a manufacturing facility in McHenry, US. The company serves healthcare professionals through comprehensive product portfolios and practice solutions.

FDA 510(k) regulatory history: Henry Schein received 8 FDA 510(k) clearances from 8 total submissions between 1978 and 2004. The company's submissions focused predominantly on Dental devices, representing 88% of its regulatory activity. Notable cleared products include air polishing units, bleaching systems, excavators, cotton rolls, and X-ray film holders.

The company is inactive in the FDA 510(k) clearance process, with no submissions recorded since 2004. This regulatory record represents a historical snapshot of the company's device development and market presence during its active period.

Explore the complete list of Henry Schein, Inc. FDA 510(k) cleared devices, including product names, device codes, and clearance dates in the database.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.