Regulatory Compliance

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)
Dental Adhesives and Composites (627K)
Non-Sterile Orthodontic Burs, Wires, Wire Locks, Springs, and Dental and Palatal Correctors (1.0MB)

Europe Declaration of Conformity Certificates

BANDS AND ATTACHMENTS

BONDING AGENTS

BRACKETS AND BONDABLE DEVICES

BUCCAL TUBES

ELASTOMERICS

FIXED AND FUNCTIONAL

ORTHODONTIC INSTRUMENTS

WIRES, SPRINGS, AND ATTACHMENTS

ORTHODONTIC SUPPLIES