510(k) K933612

JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) by Jedental Co., Inc. — Product Code EMA

K933612 is an FDA 510(k) premarket notification submitted by Jedental Co., Inc. for the device "JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)". The FDA issued a decision of Substantially Equivalent on February 24, 1994. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Jedental Co., Inc. has at least 7 other 510(k) clearances on record.