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.

CERTIFICATIONS

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 Certificates

Non-Sterile Orthodontic Bands, Brackets, Bondable Attachments, Buccal Tubes, Elastomerics, Wires, Springs, Maloclusion Correctors and Dental & Palatal Correctors (1.8MB)

Non-Sterile Orthodontic Burs, Wires, Wire Locks, Springs, Dental and Palatal Correctors, and Bonding Agents (227KB)


EUROPE DECLARATION OF CONFORMITY CERTIFICATES

Bands and Attachments

Bands & Attachments - Annex II (99K)

Bonding Agents

Bonding Agents - Class IIa (89K)

Brackets and Bondable Devices

Brackets & Bondable Devices - Annex II (107K)

Brackets & Bondable Devices - Annex V (95K)

Buccal Tubes

Buccal Tubes (90K)

Elastomerics

Elastomerics - Annex II (88K)

Elastomerics - Annex V (96K)

Fixed and Functional

Fixed & Functional - Annex II (113K)

Fixed & Functional - Annex V (114K)

Orthodontic Instruments

Orthodontic Instruments (145K)

Wires, Springs, and Attachments

Orthodontic Wires, Springs & Attachments - Annex II (104K)

Orthodontic Wires, Springs & Attachments - Annex V (111K)

Orthodontic Supplies

Orthodontic Supplies - Class I OBL (126K)

Orthodontic Supplies - Class IIa (125K)

Orthodontic Supplies - Class I MFG (82K)