Regulatory and Certifications
EU Declaration of Conformity – MDR – Orthodontic Extraoral Headgear
EU Declaration of Conformity – MDR – Bite Registration Wax
EU Declaration of Conformity – MDR – Dental Impression Trays Single Use
EU Declaration of Conformity – MDR – Mouthguard Preformed
EU Declaration of Conformity – MDR – Dental Impression Trays Reusable
EU Declaration of Conformity – MDR – Orthodontic Wire Forms
EU Declaration of Conformity – MDR – Orthodontic Tubing
EU Declaration of Conformity – MDR – Orthodontic Retainer
EU Declaration of Conformity – MDR – Dental Dryfield Devices
EU Declaration of Conformity – MDR – Orthodontic Wire
Great Lakes Dental Technologies hereby declares that the thermoforming materials, polymers, and monomers used in the manufacture of our products are Gluten-Free and BPA-Free.
Based on information provided by our material suppliers and our internal quality and regulatory assessments, we confirm the following:
Gluten-Free:
- The materials supplied to Great Lakes Dental Technologies are not formulated with gluten or gluten-derived substances. To the best of our knowledge, no gluten-containing materials are used at any stage of raw material production or in the manufacturing processes for these materials.
BPA-Free:
- The thermoforming materials, polymers, and monomers used in our products do not intentionally contain Bisphenol A (BPA), and BPA is not used as an ingredient, additive, or processing aid during the production of these materials.
Should any future change occur to the formulation, composition, or manufacturing processes that may affect the gluten-free or BPA-free status of these materials, Great Lakes Dental Technologies will update this declaration accordingly.
