510(k) K040858

ORALIEF THERAPY FOR SENSITIVE TEETH by Novamin Technology, Inc. — Product Code LBH

K040858 is an FDA 510(k) premarket notification submitted by Novamin Technology, Inc. for the device "ORALIEF THERAPY FOR SENSITIVE TEETH". The FDA issued a decision of Substantially Equivalent on September 2, 2004. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Novamin Technology, Inc. has at least 6 other 510(k) clearances on record.