New Stetic, SA - FDA 510(k) Cleared Devices

New Stetic, SA, offers comprehensive dental and surgical healthcare solutions. The company operates with a manufacturing facility in Guarne, CO, and serves a global market across 64 countries.

The company has received 2 FDA 510(k) clearances from 2 total submissions. Dental devices represent 100% of its regulatory submissions. New Stetic's FDA 510(k) clearance history spans from 2019 to 2026, demonstrating continued regulatory activity and market engagement.

The company's cleared device portfolio includes CAD/CAM disc systems and specialized dental products. These devices support prosthetic fabrication, restorative dentistry, and related clinical applications.

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

Regulatory submissions have been managed by Aclivi Consulting and Aclivi, LLC.