Medical Device Manufacturer · US , Amherst , NY

Ivoclar Vivadent, Inc. - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 2001

Total

Cleared

Denied

Ivoclar Vivadent, Inc. is a dental solutions provider based in Amherst, US. The company develops modern products for dental practitioners and laboratory technicians.

The company has received 65 FDA 510(k) clearances from 65 total submissions since 2001. Dental devices represent 97% of its regulatory portfolio. The latest clearance was issued in 2026, confirming active market engagement.

Recent cleared devices include restorative materials, adhesives, CAD-on restorations, bulk-fill composites, and curing lights. The product portfolio spans chairside and laboratory workflows for both general and specialized dental applications.

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

FDA 510(k) Regulatory Record - Ivoclar Vivadent, Inc.

65 devices

1-12 of 65