510(k) K242366

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment by Overfibers S.R.L. — Product Code EMA

K242366 is an FDA 510(k) premarket notification submitted by Overfibers S.R.L. for the device "OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment". The FDA issued a decision of Substantially Equivalent on January 10, 2025. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275.