510(k) K982692

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC by Sterngold/Implamed — Product Code EBF

K982692 is an FDA 510(k) premarket notification submitted by Sterngold/Implamed for the device "STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC". The FDA issued a decision of Substantially Equivalent on October 22, 1998. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Sterngold/Implamed has at least 10 other 510(k) clearances on record.