510(k) K081810

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL by Pulpdent Corporation — Product Code EBG

K081810 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL". The FDA issued a decision of Substantially Equivalent on September 17, 2008. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Pulpdent Corporation has at least 10 other 510(k) clearances on record.