510(k) K233395

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) by Alliage S/A Industrias Médico Odontológica — Product Code EHD

K233395 is an FDA 510(k) premarket notification submitted by Alliage S/A Industrias Médico Odontológica for the device "Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)". The FDA issued a decision of Substantially Equivalent on January 3, 2024. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800.