510(k) K974202

PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS by Pulpdent Corp. — Product Code LBH

K974202 is an FDA 510(k) premarket notification submitted by Pulpdent Corp. for the device "PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS". The FDA issued a decision of Substantially Equivalent on March 19, 1998. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Pulpdent Corp. has at least 10 other 510(k) clearances on record.