510(k) K213579

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph by Fona S.R.L — Product Code OAS

K213579 is an FDA 510(k) premarket notification submitted by Fona S.R.L for the device "Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph". The FDA issued a decision of Substantially Equivalent on Mar 2, 2022. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Fona S.R.L has 3 other 510(k) clearances on record.