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Regulatory and Compliance

AO is registered with the FDA and its quality systems are certified to ISO 13485:2016, European Union MDR 2017/745, and Medical Device Single Audit Program (MDSAP), a program that demonstrates compliance in Australia, Brazil, Canada, Japan and the United States. AO has also gone through the rigor of registering products with regulatory authorities in over 75 different countries.


ISO 13485 Quality System Certification

ISO 13485:2016 Certificate (107K)

MDSAP Certificate (127K)

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

Europe - EC Certificate

MDR Certificate (409K)

MDD Certificate - Annex II (368K)

MDD Certificate - Annex V (252K)



Class I Devices (803K)

Class IIa Devices (445K)


Bands & Attachments - Annex II (195K)

Bonding Agents - Annex V (198K)

Buccal Tubes - Annex II (197K)

Elastomerics - Annex II (195K)

Elastomerics - Annex V (205K)

Fixed & Functional - Annex II (212K)

Fixed & Functional - Annex V (195K)

Orthodontic Instruments - Class Ir (199K)

Orthodontic Wires, Springs & Attachments - Annex II (206K)

Orthodontic Wires, Springs & Attachments - Annex V (207K)