510(k) K901257

WIRONTOM CLASP WIRE by Ivoclar North America, Inc. — Product Code EJW

K901257 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "WIRONTOM CLASP WIRE". The FDA issued a decision of Substantially Equivalent on April 25, 1990. The device falls under product code EJW (Clasp, Wire), a Class I device regulated under 21 CFR 872.3285. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.