Medical Device Manufacturer · MX , Mexico City

Clemde SA DE CV - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023

Total

Cleared

Denied

Clemde SA DE CV, is a Mexican manufacturer and distributor of materials and systems for dental technicians. The company operates with a manufacturing facility in Mexico City, MX. Founded in 1999, Clemde has built a portfolio of over 200 products serving the global dental market.

The company has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on Dental devices. First clearance was in 2023, with the most recent clearance in 2025, demonstrating active ongoing regulatory engagement. Clemde's cleared Dental devices include systems for flexible denture manufacturing and PEEK pressing applications.

The company specializes in laboratory systems and materials, including injection presses, digital ovens, and specialized polymers. Products feature biocompatible materials with ISO 13485:2013 certification and international testing validation. Clemde offers training courses alongside its equipment and material lines.

Explore the company's FDA 510(k) clearance history, device names, and submission dates in the regulatory database.

FDA 510(k) Regulatory Record - Clemde SA DE CV

2 devices

1-2 of 2