510(k) K892937

REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS by Dentsply Intl. — Product Code JDZ

K892937 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code JDZ (Mixer, Cement, For Clinical Use), a Class I device regulated under 21 CFR 888.4210. Dentsply Intl. has at least 10 other 510(k) clearances on record.