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
MDR Certificate (409K)
MDD Certificate - Annex II (368K)
MDD Certificate - Annex V (252K)
EUROPE DECLARATIONS OF CONFORMITY
MDR
Class I Devices (803K)
Class IIa Devices (445K)
MDD
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)