510(k) K000686

KROM-ALGINATE AND ALGINATE PLUS by Cavex Holland BV — Product Code ELW

K000686 is an FDA 510(k) premarket notification submitted by Cavex Holland BV for the device "KROM-ALGINATE AND ALGINATE PLUS". The FDA issued a decision of Substantially Equivalent on May 25, 2000. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Cavex Holland BV has at least 10 other 510(k) clearances on record.