Our manufacturing and distribution facilities are designed and managed to meet the highest standards of quality control. Our manufacturing facility meets all of the recognized international standards including ISO 13485:2016 CMCDCAS, FDA GMP, Health Canada and the CE standards
We are committed to providing the highest quality product possible and to continually improving our designs and manufacturing processes. You can be confident when you purchase Flight dental equipment, that you are purchasing the very best.
ELT Mark
The ETL Listed Mark is proof of product compliance (electrical, gas, and other safety standards) to North American safety standards, including UL, ANSI, CSA, ASTM and NFPA standards.
FDA 510K Premarket Authorization
This authorization relies on the use of guidance documents, special controls, and recognized standards. FDA is authorized to recognize all of part of national and international consensus standards through publication of a notice in the Federal Register. Recognized standards could be cited in guidance documents or individual policy statements, or established as special controls that address specific risks associated with a type of device.
ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices.
Health Canada Device License
Health Canada is the federal regulator of therapeutic products, including medical devices. The Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate, Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with the Food and Drugs Act and Regulations and the Medical Devices Regulations.
Questions? We have answers…
If you have any questions regarding our certificates or need more information, please use the following form to contact us and one of our professional team will get back to as soon as possible.
Upcoming Events
SmileCon is the ADA’s reimagined annual meeting, offering continuing education, networking opportunities, hundreds of exhibitors, social events, and fun! SmileCon 2023 will take place on Oct. 5–7 in Orlando, FL, at the Orange County Convention Center in the South Building. Registration opens June 7 here at SmileCon.org. Early Bird deadline is June 23 at 5 p.m.
Welcome to the 99th Annual Greater New York Dental Meeting! We invite you to participate in one of the largest Dental Congresses in the United States. At our 2022 Meeting, we hosted over 30,000 healthcare professionals at the Jacob K. Javits Convention Center, featuring over 1,600 Technical Exhibits which demonstrated the newest technology for the
Latest News
MK Dent / Flight Contra Angle Attachment – Press Release
BRAMPTON, ON - Available immediately from Flight Dental Systems is the MK Dent / Flight Dental ECO Line -
