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)

CERAMIC BRACKETS — EU/CE Class IIa

WIRES (SPRINGS) — EU/CE Class IIa

  • 858.170201 (245K) – Nickel Titanium Memory Springs, NiTi Springs

LINGUAL ATTACHMENTS — EU/CE Class IIa

FIXED & FUNCTIONAL — EU/CE Class IIa

ORTHODONTIC WIRES — EU/CE Class IIa

  • 857.170201 (239K) – Power Pin
  • 858.170201 (245K) – Therma-Ti®, Therma-Ti® Lite, Therma-Ti® "D", Tritanium™, Beta Titanium Wire, Stainless Steel Wire, Force Two NiTi Wire, Gold Tone, Stainless Steel Multi-Strand
  • 859.170201 (262K) – Beta Titanium Wire, Stainless Steel Wire, Stainless Steel Multi-Strand, Force Two NiTi Wire, Gold Tone, Gold Coated, Kobayashi Hooks, Orientation Pin

ADHESIVES — EU/CE Class IIa

  • 856-170201 (246K) – Bandtite™ Band Cement, MR Lock LC™, No Mix: 30™, Eagle FluorSure™, Acid Etching (Gel, Semi-Gel, Liquid), Porcelain Conditioner, Eagle Spectrum™, Eagle No Drift™, Eagle MTP™, Eagle Sealant, Sealant

Declaration of Conformity Certificates

BONDING AGENTS

BRACKETS AND BONDABLE DEVICES

BUCCAL TUBES

ELASTOMERICS

ORTHODONTIC INSTRUMENTS

WIRES, SPRINGS, AND ATTACHMENTS