510(k) K993716

PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE by Harry J. Bosworth Co. — Product Code EBF

K993716 is an FDA 510(k) premarket notification submitted by Harry J. Bosworth Co. for the device "PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Harry J. Bosworth Co. has at least 10 other 510(k) clearances on record.