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
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)