Int’l Regulatory Compliance

BEYOND Dental & Health executes International Regulatory Compliance processes and procedures to provide high quality, professional aesthetic dentistry products.

For reference purposes, downloadable documents are listed below.  For questions, contact us at or contact your regional headquarters.


ISO 13485 quality system certification (PDF format)
ISO 13485:2003 certificate
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations


AUSTRALIA – Devices listed in ARTG (Links to TGA website)

All Beyond Chair-side Whitening Accelerators | e-Bright Whitening Accelerator Home Edition | LED Curing Light | BlueSeal Gingival Protection | FlexiBlue Cheek Retractor | 6% Hydrogen Peroxide Whitening Gel | Impact Tools

CANADA- Cosmetic device licenses (PDF format)

e-Bright Tooth Whitening Accelerator Home Edition

EUROPE – CE Marking certificates (PDF format)

CE Annex II | CE Annex II – Product List

EUROPE – Declarations of Conformity (PDF format)

Beyond Whitening Accelerator| Beyond COMMAND Whitening Accelerator | WhiteSpa Whitening Accelerator | WhiteSpa Select Whitening Accelerator | Complete Whitening Kit | Premier Whitening Kit| Five Patient Economy Kit | Max5 Whitening Kit