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International Regulatory Compliance Information
This page displays BEYOND™ Dental & Health’s international regulatory compliance information. All contact information, hyperlinks, and downloadable documents are for reference only and are subject to change without notice.
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- Medical device licenses (Links to Health Canada website) PENDING. For copies, email us.
CANADA- Cosmetic device licenses (PDF format)PENDING. For copies, email us.
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 | Max10 Whitening Kit | StayWhite Tray System | StayWhite Refill | Cordless LED Curing Light | Impact Tools | BlueSeal Gingival Protection | FlexiBlue Cheek Retractor | e-Bright Tooth Whitening System Home Edition | e-Bright Refill
ITALY – Registration in Italian Ministry of Health Database (PDF format) PENDING. For copies, email us.
ITALY – Declarations of Conformity (PDF format) PENDING. For copies, email us.
UNITED STATES – FDA CDRH Device Registration Listing (Links to US FDA database device listing)
All Beyond Chair-side Whitening Accelerators | LED Curing Light | e-Bright Whitening Accelerator Home Edition | Xspand Dental Floss | FlexiBlue Cheek Retractor | ClearView Odontoscope | Matrix | BlueSeal Gingival Protection | Impact Instruments | Insight Shade Taking Device | CONTROL Spray
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs issues and incident reporting. For a list of our distributors worldwide, please click here.
AUSTRALIA – Sponsor Representative
Emergo Australia Pty. Ltd., Sydney, AUSTRALIA
Telephone: +61.2.9006.1662
http://www.EmergoGroup.com
CHINA – Legal Agent & After Sales Agent
Beyond Technology Corp., Beijing, CHINA
Telephone: +86.10.5877.2600
Email: info@beyonddent.com
http://www.beyonddent.com.cn
EUROPE – Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
JAPAN – Designated Marketing Authorization Holder
JBA Inc., Tokyo, JAPAN
Telephone: +81.3.5724.6601
http://www.beyondsystem.com
UNITED STATES – US Agent representative
Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997
http://www.EmergoGroup.com
