Are OPRO mouthguards safety tested?Updated 5 hours ago
Yes. All OPRO mouthguards are certified as personal protective equipment (PPE) under EU Regulation 2016/425 and carry the CE mark. Each range is independently tested and certified by SATRA, a notified body, to the SATRA M33:2022 mouthguard standard. Our Night Guard is a Class I medical device.
You can view and download the Declaration of Conformity and certificate for each product on our Declarations of Conformity page.
If you need a document that isn’t listed there, please contact us.