hdr regulatory

Regulatory and Compliance

AO products have gone through the rigor of registering products with regulatory authorities in over 75 different countries and our quality systems are fully compliant with US FDA, UDI, CE, Health Canada, PMDA (Japan), TGA (Australia), Anvisa (Brazil) and ISO 13485.


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

EC Certificate (227KB)

MDR Certificate (409KB)


Bands and Attachments

Bands & Attachments - Annex II (195K)

Bonding Agents

Bonding Agents - Annex V (198K)

Orthodontic Brackets, Bondable Devices & Tubes

Declaration of Conformity - Orthodontic Brackets, Bondable Devices & Tubes (126K)

Buccal Tubes

Buccal Tubes - Annex II (197K)


Elastomerics - Annex II (195K)

Elastomerics - Annex V (205K)

Elastomerics - Annex V - Class I (196K)

Fixed and Functional, Extra Oral

Fixed & Functional - Annex II (212K)

Fixed & Functional - Annex II - Class I (191K)

Fixed & Functional - Annex V (195K)

Fixed & Functional - Annex V - Class I (53K)

Orthodontic Instruments

Orthodontic Instruments - Class I (216K)

Orthodontic Instruments - Class Ir (199K)

Wires, Springs, and Attachments

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

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

Orthodontic Supplies

Orthodontic Supplies - Class IIa (197K)

Orthodontic Supplies - Class I (202K)