Regulatory Compliance

International Regulatory Compliance Information

Listed below are regulatory compliance information that is frequently requested by customers. If you need any documents listed below legalized or apostilled, please send your request to the following: regulatory@americanortho.com

Quality Management System

ISO 13485 Quality System Certification
ISO 13485:2016 Certificate (107K)
MDSAP Certificate (127K)
CMDCAS ISO 13485 Quality System Certification (107K)

US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR 820, US FDA Quality Systems Regulations.

Notified Body/ Registrar/ Certification Body

American Orthodontics maintains ISO 13485:2003 Certification and is audited every year by:

Underwriter's Laboratory (UL) LLC
Northbrook, IL
http://www.ul.com/global/eng/pages/

Product Certifications and Approvals

Australia - Devices listed in ARTG
http://www.tga.gov.au/industry/artg.htm

Canada - Medical Device Licenses
http://www.hc-sc.gc.ca/dhp-mps/md-im/licen/mdlic-end.php

Europe - CE Marketing Certificates
CE Certificate (422K)

Declaration of Conformity Certificates

BANDS AND ATTACHMENTS

BONDING AGENTS

BRACKETS AND BONDABLE DEVICES

BUCCAL TUBES

ELASTOMERICS

FIXED AND FUNCTIONAL

ORTHODONTIC INSTRUMENTS

WIRES, SPRINGS, AND ATTACHMENTS