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 Certificate
EC Certificate (227KB)
MDR Certificate (409KB)
EUROPE DECLARATION OF CONFORMITY CERTIFICATES
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
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