510(k) K984044

QUADRANT POSTERIOR DENSE by Cavex Holland BV — Product Code EBF

K984044 is an FDA 510(k) premarket notification submitted by Cavex Holland BV for the device "QUADRANT POSTERIOR DENSE". The FDA issued a decision of Substantially Equivalent on December 16, 1998. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Cavex Holland BV has at least 10 other 510(k) clearances on record.