510(k) K102640

VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS by Vertex-Dental B.V. — Product Code EBI

K102640 is an FDA 510(k) premarket notification submitted by Vertex-Dental B.V. for the device "VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS". The FDA issued a decision of Substantially Equivalent on Mar 25, 2011. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Vertex-Dental B.V. has at least 7 other 510(k) clearances on record.