510(k) K933656

JEDENTAL PSROFILL SELF-CURE COMPOSITE by Jedental Co., Inc. — Product Code EBF

K933656 is an FDA 510(k) premarket notification submitted by Jedental Co., Inc. for the device "JEDENTAL PSROFILL SELF-CURE COMPOSITE". The FDA issued a decision of Substantially Equivalent on November 17, 1993. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Jedental Co., Inc. has at least 7 other 510(k) clearances on record.