510(k) K071267

PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN by Novamin Technology, Inc. — Product Code LBH

K071267 is an FDA 510(k) premarket notification submitted by Novamin Technology, Inc. for the device "PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN". The FDA issued a decision of Substantially Equivalent on May 18, 2007. 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.