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

For reference purposes, downloadable documents or links registrations are listed below. For questions regarding local registrations or device classification, contact us at info@beyonddent.com or contact your regional headquarters.

QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification (PDF format)

ISO 13485:2012 + AC2012 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

EUROPE - CE Marking certificates (PDF format)

CE Annex II

EUROPE - Declarations of Conformity (PDF format)

BEYOND Polus Whitening Accelerator | Beyond Whitening Accelerator | Beyond COMMAND Whitening Accelerator | BEYOND Inform Vacuum Machine | BEYOND BlueSeal Gingival Protection | BEYOND FlexiBlue Cheek Retractors | BEYOND Cordless LED Mini Curing Light | BEYOND Polus Curing Light | BEYOND Clear View LED Professional Odontoscope | BEYOND Impact Composite & Plastic Filling Instruments | BEYOND StayWhite Professional Tray Whitening System | BEYOND StayWhite Refill Kit | BEYOND II 35% H2O2 Whitening Gel Syringe | BEYOND Solo Whitening Treatment Kit | BEYOND II Complete Whitening Treatment Kit for Severe Stains | BEYOND II Complete Whitening Treatment Kit with Tray Material | BEYOND II Five- Patient Economy Whitening Treatment Kit | BEYOND Max5 Whitening Treatment Kit | BEYOND Max10 Whitening Treatment Kit | BEYOND Blast Pre- Treatment Manual-Mix Whitening Treatment Kit

United States FDA Establishment Registration & Device Listing (Links to FDA website)

Beyond Dental & Health Inc | Beyond Technology Corp Nanchang

ITALY – Devices listed with Ministry of Health (PDF Format)

Medical Device Directory listing