510(k) K080514

PECD-01 AND PECD QUICK-01 by 3M Espe AG Dental Products — Product Code ELW

K080514 is an FDA 510(k) premarket notification submitted by 3M Espe AG Dental Products for the device "PECD-01 AND PECD QUICK-01". The FDA issued a decision of Substantially Equivalent on March 26, 2008. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. 3M Espe AG Dental Products has at least 10 other 510(k) clearances on record.