510(k) K920460

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL by Pulpdent Corp. — Product Code ELL

K920460 is an FDA 510(k) premarket notification submitted by Pulpdent Corp. for the device "4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL". The FDA issued a decision of Substantially Equivalent on April 28, 1992. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Pulpdent Corp. has at least 10 other 510(k) clearances on record.