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  info@tmdsupplies.com or contact your regional headquarters.

QUALITY MANAGEMENT SYSTEM

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

PRODUCT CERTIFICATIONS AND APPROVALS

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