Quality System Certificates

All Quality System Certificates for our highspeed dental handpieces are in Adobe Reader PDF Format. 

US19/819943593 (MDD)

European Union Medical Device Directive Quality System certificate (CE certificate) for high-speed dental handpieces, low-speed dental handpieces and dental handpiece couplers.

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US97/9623 (ISO 13485)

Quality System certificate for ISO 13485:2016 Medical Device Quality System requirements for the design, manufacture, service & distribution of High-speed Dental Handpieces.

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US20/819943831 (MDSAP)

Design and development, manufacture, distribution and servicing of dental handpieces and dental handpiece couplers.


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