Certificates

Alpha Dent Implants GmbH

Alpha Dent Implants GmbH is a manufacturer of medical devices committed to adhering to the highest standards of quality and international regulatory compliance.

Our company is certified under the ISO 13485 Quality Management System, demonstrating our dedication to meeting stringent requirements for the production of medical devices.

Furthermore, Alpha Dent Implants GmbH fully complies with the European Union Medical Device Regulation (MDR) 2017/745, ensuring the highest patient safety and performance levels.

We are also proud to hold FDA 510(k) clearance, which allows us to market our products in the United States and affirms their compliance with the rigorous safety and performance standards set by the U.S. Food and Drug Administration.

Alpha Dent Implants GmbH continues to enhance its processes and products to deliver reliability and exceed our customers‘ expectations worldwide.