510(k) K240888

Calibra Abutment Resin Cement by Dentsply Sirona — Product Code EMA

K240888 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Calibra Abutment Resin Cement". The FDA issued a decision of Substantially Equivalent on April 2, 2024. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Dentsply Sirona has at least 10 other 510(k) clearances on record.