510(k) K930835

VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A by Ivoclar North America, Inc. — Product Code ELL

K930835 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A". The FDA issued a decision of Substantially Equivalent on July 22, 1994. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.