510(k) K062176

RELIEF ACP ORAL CARE GEL by Discus Dental, Inc. — Product Code LBH

K062176 is an FDA 510(k) premarket notification submitted by Discus Dental, Inc. for the device "RELIEF ACP ORAL CARE GEL". The FDA issued a decision of Substantially Equivalent on January 10, 2007. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Discus Dental, Inc. has at least 10 other 510(k) clearances on record.