World Class Technology/OC Orthodontics will be discontinuing the sale of Hype Brackets. This discontinuation is due to difficulties in obtaining technical documentation from a supplier as required by the EU Medical Device Regulation 2017/745.
The effective date is 2023-02-15.
World Class Technology/OC Orthodontics places the utmost value on regulatory compliance. While reviewing the technical documentation for all our products, it was identified that the supplier of the Hype Bracket family was unable to meet our requests in a timely manner. While Hype products are currently certified under the MDD transition rules, we will not be able to continue with this product as we move to the rules of the MDR.
We apologize for any inconvenience and appreciate your attention and cooperation in this matter. Please see attached notice for a list of affected part numbers.
Please contact Ashley Sanchez at ashley.s@oc-orthodontics.com if you have any questions or need further information.
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